Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03675360
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kdorans@tulane.edu', 'phone': '15049880883', 'title': 'Dr. Kirsten Dorans, Assistant Professor, Department of Epidemiology', 'organization': 'Tulane University School of Public Health and Tropical Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each participant, adverse event data was collected over the 6-month intervention period.', 'eventGroups': [{'id': 'EG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 2, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 2, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Emergency room visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Room Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emergency Room Visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgery and hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '-0.19'}, {'value': '-0.04', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.02'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '-0.14', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed using intention to treat. For the primary outcome (net 6-month change in HbA1c), we used linear mixed effects models with HbA1c as the dependent variable. This model included a random intercept with an unstructured covariance matrix, indicator variables for time and study group, and group by time interaction terms.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.4', 'groupId': 'OG000', 'lowerLimit': '-12.3', 'upperLimit': '-4.4'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.3', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '-4.9', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'groupId': 'OG000', 'lowerLimit': '-7.9', 'upperLimit': '-1.8'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '1.2'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '0.9', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Change in Total-to-HDL-cholesterol Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'groupId': 'OG000', 'lowerLimit': '-0.67', 'upperLimit': '-0.40'}, {'value': '-0.41', 'groupId': 'OG001', 'lowerLimit': '-0.52', 'upperLimit': '-0.29'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.05', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.4', 'groupId': 'OG000', 'lowerLimit': '-7.8', 'upperLimit': '-5.1'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '-4.4', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in body weight comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '-0.8'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '5.0'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '-2.0', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in fasting insulin comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'μIU/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '-0.7'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '-1.1', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in HOMA-IR comparing low-carbohydrate arm with usual diet arm. HOMA-IR was calculated as fasting insulin (μIU/mL) x fasting glucose (mmol/L)/22.5.', 'unitOfMeasure': 'no units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-1.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '1.1'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '0', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in diastolic blood pressure comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '-3.5'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '-2.6', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in waist circumference comparing low-carbohydrate arm with usual diet arm', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Estimated Atherosclerotic Cardiovascular Disease Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'OG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-0.9'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '-0.2'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.3', 'statisticalMethod': 'linear mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and six months', 'description': '6-month change in estimated 10-year atherosclerotic cardiovascular disease risk comparing low-carbohydrate arm with usual diet arm.\n\nThe estimated 10-year cardiovascular disease risk was assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score, known as the Pooled Cohort Equations. The Pooled Cohort Equations estimate the 10-year primary risk of ASCVD (atherosclerotic cardiovascular disease) among patients without pre-existing cardiovascular disease who are between 40 and 79 years of age. Variables included in the risk score include: gender, age, race, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for blood pressure, diabetes, and smoking status.\n\nReference: Goff DC, Lloyd-Jones DM et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: A report of the American college of cardiology/American heart association task force on practice guidelines. Vol. 129, Circulation. 2014.', 'unitOfMeasure': 'estimated %', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'FG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Recruitment occurred from September 2018 through December 2020. Participants were recruited from the greater New Orleans, Louisiana area, primarily by mass mailing', 'preAssignmentDetails': 'After ascertaining eligibility, staff obtained randomization assignment in either a sealed envelope from or by telephoning the methodology unit at the time of randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.\n\nLow-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.'}, {'id': 'BG001', 'title': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '102.6', 'spread': '21.8', 'groupId': 'BG000'}, {'value': '96.4', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '99.5', 'spread': '20.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '115.9', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '111.8', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '113.9', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '6.17', 'spread': '0.31', 'groupId': 'BG000'}, {'value': '6.14', 'spread': '0.30', 'groupId': 'BG001'}, {'value': '6.16', 'spread': '0.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-14', 'size': 537431, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-28T18:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2018-09-14', 'resultsFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2018-09-16', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-31', 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Insulin', 'timeFrame': 'Baseline and six months', 'description': '6-month change in fasting insulin comparing low-carbohydrate arm with usual diet arm'}, {'measure': 'Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline and six months', 'description': '6-month change in HOMA-IR comparing low-carbohydrate arm with usual diet arm. HOMA-IR was calculated as fasting insulin (μIU/mL) x fasting glucose (mmol/L)/22.5.'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline and six months', 'description': '6-month change in diastolic blood pressure comparing low-carbohydrate arm with usual diet arm'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Baseline and six months', 'description': '6-month change in waist circumference comparing low-carbohydrate arm with usual diet arm'}, {'measure': 'Change in Estimated Atherosclerotic Cardiovascular Disease Risk', 'timeFrame': 'Baseline and six months', 'description': '6-month change in estimated 10-year atherosclerotic cardiovascular disease risk comparing low-carbohydrate arm with usual diet arm.\n\nThe estimated 10-year cardiovascular disease risk was assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score, known as the Pooled Cohort Equations. The Pooled Cohort Equations estimate the 10-year primary risk of ASCVD (atherosclerotic cardiovascular disease) among patients without pre-existing cardiovascular disease who are between 40 and 79 years of age. Variables included in the risk score include: gender, age, race, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for blood pressure, diabetes, and smoking status.\n\nReference: Goff DC, Lloyd-Jones DM et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: A report of the American college of cardiology/American heart association task force on practice guidelines. Vol. 129, Circulation. 2014.'}], 'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c', 'timeFrame': 'Baseline and six months', 'description': '6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Baseline and six months', 'description': '6-month change in fasting plasma glucose comparing low-carbohydrate arm with usual diet arm'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline and six months', 'description': '6-month change in systolic blood pressure comparing low-carbohydrate arm with usual diet arm'}, {'measure': 'Change in Total-to-HDL-cholesterol Ratio', 'timeFrame': 'Baseline and six months', 'description': '6-month change in total-to-HDL-cholesterol ratio comparing low-carbohydrate arm with usual diet arm'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Baseline and six months', 'description': '6-month change in body weight comparing low-carbohydrate arm with usual diet arm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prediabetes', 'Diabetes', 'Low-Carbohydrate Diet'], 'conditions': ['Diabetes', 'PreDiabetes', 'Metabolic Disease', 'Hyperglycemia', 'Diet Modification', 'Glucose Intolerance', 'Glucose Metabolism Disorders (Including Diabetes Mellitus)', 'Endocrine System Diseases']}, 'referencesModule': {'references': [{'pmid': '36287562', 'type': 'DERIVED', 'citation': "Dorans KS, Bazzano LA, Qi L, He H, Chen J, Appel LJ, Chen CS, Hsieh MH, Hu FB, Mills KT, Nguyen BT, O'Brien MJ, Samet JM, Uwaifo GI, He J. Effects of a Low-Carbohydrate Dietary Intervention on Hemoglobin A1c: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238645. doi: 10.1001/jamanetworkopen.2022.38645."}, {'pmid': '33522954', 'type': 'DERIVED', 'citation': "Dorans KS, Bazzano LA, Qi L, He H, Appel LJ, Samet JM, Chen J, Mills KT, Nguyen BT, O'Brien MJ, Uwaifo GI, He J. Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial. Trials. 2021 Feb 1;22(1):108. doi: 10.1186/s13063-020-05001-x."}]}, 'descriptionModule': {'briefSummary': 'The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.', 'detailedDescription': 'In the short-term, among patients with type 2 diabetes, low-to-moderate carbohydrate diets have a greater glucose-lowering effect than do high-carbohydrate diets. However, compared with usual diet, the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern among individuals with prediabetes or untreated type 2 diabetes is not well understood.\n\nThe overall goal of this randomized controlled trial is to study the effect of a behavioral intervention promoting a low-carbohydrate/high-unsaturated fat and high-protein dietary pattern compared with usual diet on hemoglobin A1c (HbA1c) and other metabolic risk factors among individuals with or at high risk of diabetes (HbA1c 6.0-6.9%).\n\nA total of 150 participants with HbA1c 6.0-6.9% will be recruited and randomly assigned to either a 6-month behavioral modification program designed to reduce carbohydrate intake (initial target \\<40 g digestible carbohydrates, final target \\<60 g digestible carbohydrates) or to usual diet in a 1:1 randomization ratio.\n\nThe primary outcome will be the difference between the active intervention and control groups for change in HbA1c from baseline to 6 months. Secondary outcomes will be fasting glucose, systolic blood pressure, total-to-high-density lipoprotein-cholesterol ratio, and body weight.\n\nFindings from this study may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women ages 40 to 70 years\n* HbA1c 6.0-6.9%\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Diagnosed type 1 diabetes mellitus\n* Use of agents affecting glycemic control (medications for diabetes, oral glucocorticoids) within the past three months prior to enrollment\n* Medical condition in which low-carbohydrate diet may not be advised: estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m²; self-report of liver disease due to hepatitis or alcohol; osteoporosis; untreated thyroid disease; gout; cancer (other than non-melanoma skin cancer) requiring treatment in the past year, unless prognosis is excellent\n* Factors that may affect HbA1c: hemoglobin \\<11 mg/dL (cutpoint for moderate-to-severe anemia, which could lead to falsely elevated or lowered HbA1c); recent blood donation or blood transfusion (self-report, past 4 months); human immunodeficiency virus (self-report)\n* Self-reported history of intensive care unit stay due to Coronavirus Disease 2019 (COVID-19) in the past three months, as severe COVID-19 may affect blood glucose levels\n* Allergies to nuts\n* For women, current pregnancy, breastfeeding, or plans to become pregnant during the study\n* Consumption of ≥21 alcoholic drinks per week or consumption of ≥6 drinks per occasion\n* Current or planned residence making it difficult to meet trial requirements (due to distance from study site and/or challenges regularly traveling to site)\n* Current participation in another lifestyle intervention trial or a pharmaceutical trial\n* Participation of another household member in the study; employees or persons living with employees of the study\n* Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator'}, 'identificationModule': {'nctId': 'NCT03675360', 'acronym': 'ADEPT', 'briefTitle': 'Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial', 'orgStudyIdInfo': {'id': '2018-053'}, 'secondaryIdInfos': [{'id': 'P20GM109036', 'link': 'https://reporter.nih.gov/quickSearch/P20GM109036', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.', 'interventionNames': ['Behavioral: Low-Carbohydrate Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Diet', 'description': 'No dietary intervention.\n\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}], 'interventions': [{'name': 'Low-Carbohydrate Diet', 'type': 'BEHAVIORAL', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\<40 g net carbohydrates per day for first 3 months; \\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\n\nAt baseline, participants will receive written information with standard physical activity recommendations.', 'armGroupLabels': ['Low-Carbohydrate Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Office of Health Research', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Kirsten Dorans, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University School of Public Health and Tropical Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University School of Public Health and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kirsten Dorans', 'investigatorAffiliation': 'Tulane University School of Public Health and Tropical Medicine'}}}}