Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-03 @ 11:43 PM
Study NCT ID:
NCT04416204
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2020-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbasu@uabmc.edu', 'phone': '2059341200', 'title': 'Dr. Rita Basu', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '• Though unlikely, it is possible that additional steps to load hepatic glycogen maybe necessary (e.g., late night snack: high carb in GL and isocaloric low carb in NGL) to maximize differences in liver glycogen contents between visits.'}}, 'adverseEventsModule': {'timeFrame': 'Across the study duration. GL or NGL meal for a period of 3 days and an overnight infusion protocol, followed by washout for approximately 3-6 weeks. Second visit GL or NGL meal for a period of 3 days and an overnight infusion protocol.', 'description': 'There are no safety endpoints as there were no drugs involved and study risks were limited to that of blood draw only.', 'eventGroups': [{'id': 'EG000', 'title': 'Type 2 Diabetes - GL Then NGL', 'description': 'Participants with Type 2 Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Type 2 Diabetes - NGL Then GL', 'description': 'Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants Without Diabetes - GL Then NGL', 'description': 'Participants with no Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Participants Without Diabetes - NGL Then GL', 'description': 'Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes - Glycogen Loading', 'description': 'Type 2 Diabetes after a Glycogen Loading meal'}, {'id': 'OG001', 'title': 'Type 2 Diabetes - Non-Glycogen Loading', 'description': 'Type 2 Diabetes after a Non-Glycogen Loading meal'}], 'classes': [{'title': 'GNG (umol/kgFFM/min)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '10.5'}]}]}, {'title': 'EGP (umol/kgFFM/min)', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '18.7'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks', 'description': 'We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.', 'unitOfMeasure': 'umol/kgFFM/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Gluconeogenesis (GNG) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects with type 2 diabetes.'}, {'type': 'SECONDARY', 'title': 'Rates of Glycogenolysis in Subjects With Type 2 Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type 2 Diabetes - Glycogen Loading', 'description': 'Type 2 Diabetes after a Glycogen Loading meal'}, {'id': 'OG001', 'title': 'Type 2 Diabetes - Non-Glycogen Loading', 'description': 'Type 2 Diabetes after a Non-Glycogen Loading meal'}], 'classes': [{'title': 'GGL (umol/kgFFM/min)', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '10.8'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '7.9'}]}]}, {'title': 'EGP (umol/kgFFM/min)', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '18.7'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '17.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks', 'description': 'Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.', 'unitOfMeasure': 'umol/kgFFM/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Glycogenolysis (GGL) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects with type 2 diabetes.'}, {'type': 'SECONDARY', 'title': 'Rates of Gluconeogenesis in Healthy Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Without Diabetes - Glycogen Loading', 'description': 'Participants without Diabetes after a Glycogen Loading meal'}, {'id': 'OG001', 'title': 'Participants Without Diabetes - Non- Glycogen Loading', 'description': 'Participants without Diabetes after a Non- Glycogen Loading meal'}], 'classes': [{'title': 'GNG (umol/kgFFM/min)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '8.9'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '9.7'}]}]}, {'title': 'EGP(umol/kgFFM/min)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '17.2'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '14.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks', 'description': 'Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.', 'unitOfMeasure': 'umol/kgFFM/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Gluconeogenesis (GNG) and Endogenous Glucose Production (EGP) measured after glycogen loading (GL) or no glycogen loading (NGL) in subjects without diabetes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Type 2 Diabetes - GL Then NGL', 'description': 'Participants with Type 2 Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout'}, {'id': 'FG001', 'title': 'Type 2 Diabetes - NGL Then GL', 'description': 'Participants with Type 2 Diabetes received Non-Glycogen loading (NGL) followed by Glycogen loading (GL) meal after 3-6 weeks of washout'}, {'id': 'FG002', 'title': 'Participants Without Diabetes - GL Then NGL', 'description': 'Participants with no Diabetes received Glycogen loading (GL) followed by Non-Glycogen loading (NGL) meal after 3-6 weeks of washout'}, {'id': 'FG003', 'title': 'Participants Without Diabetes - NGL Then GL', 'description': 'Participants with no Diabetes received Non-Glycogen loading (NGL)followed by Glycogen loading (GL) meal after 3-6 weeks of washout'}], 'periods': [{'title': 'First Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout (3-6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Second Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '17 Type 2 Diabetes subjects were screened, 1 subject did not meet eligibility criteria, 2 subjects withdrew from the study.\n\n17 subjects without Diabetes were screened, 2 subjects withdrew from the study.', 'preAssignmentDetails': 'Subject enrolled after consent were screened to meet inclusion criteria. If not met subjects were excluded.\n\n14 Type 2 Diabetes and 15 without Diabetes subjects were randomized to receive, either Glycogen loading or Non-Glycogen loading meal during visit 1. All subjects were tested for Glycogen loading and Non-Glycogen loading meal in a randomized order.\n\n1Type 2 Diabetes and 2 without Diabetes subjects did not participate in visit 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Type 2 Diabetes', 'description': 'High Carbohydrate (glycogen loading): Subjects will consume an isocaloric diet \\[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\\] for 3 days prior to the overnight study.\n\nLow carbohydrate (No Glycogen Loading): Subjects will consume an isocaloric diet \\[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\\] for 3 days prior to the overnight study.\n\nBaseline characteristics of all subjects with Type 2 Diabetes reported.'}, {'id': 'BG001', 'title': 'Participants Without Diabetes', 'description': 'High Carbohydrate (glycogen loading): Subjects will consume an isocaloric diet \\[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\\] for 3 days prior to the overnight study.\n\nLow carbohydrate (No Glycogen Loading): Subjects will consume an isocaloric diet \\[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\\] for 3 days prior to the overnight study.\n\nBaseline characteristics of all subjects without Diabetes reported.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Body Weight (Kg)', 'classes': [{'categories': [{'measurements': [{'value': '82.4', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '82.5', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '82.4', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (Kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (mmol/L)', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1C', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of Glycosylated Haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-27', 'size': 179851, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-07T18:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'A total of 34 subjects participated.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2020-06-01', 'resultsFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-29', 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes', 'timeFrame': 'Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks', 'description': 'We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.'}], 'secondaryOutcomes': [{'measure': 'Rates of Glycogenolysis in Subjects With Type 2 Diabetes', 'timeFrame': 'Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks', 'description': 'Rates and contribution of glycogenolysis (GLY) to nocturnal EGP will be measured using the deuterated water technique after glycogen loading and no glycogen loading in subjects with type 2 diabetes.'}, {'measure': 'Rates of Gluconeogenesis in Healthy Subjects', 'timeFrame': 'Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks', 'description': 'Rates of GNG will be measured through the night using the deuterated water technique after either glycogen loading or no glycogen loading in healthy subjects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'hepatic glycogen', 'endogenous glucose production'], 'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. Both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.', 'detailedDescription': 'Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-75\n* BMI 20-35kg/m\\^2\n* Participants with type 2 diabetes:\n\n * HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Morbidities precluding participation\n* Participants with type 2 diabetes:\n\n * Therapy with insulin\n * SGLT2 inhibitors\n * GLP-1 based approaches\n * TZDs\n * Unstable diabetic retinopathy\n * Microalbuminuria\n * Macrovascular disease\n * Medications affecting GI motility (eg., erythromycin, pramlintide)\n * Upper GI disorder/surgery\n* Participants without diabetes:\n\n * Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance\n * History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes'}, 'identificationModule': {'nctId': 'NCT04416204', 'briefTitle': 'Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Role of Hepatic Glycogen on Nocturnal EGP in T2D', 'orgStudyIdInfo': {'id': '22074'}, 'secondaryIdInfos': [{'id': 'R01DK029953', 'link': 'https://reporter.nih.gov/quickSearch/R01DK029953', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Type 2 diabetes', 'description': 'Participants with Type 2 Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.', 'interventionNames': ['Other: glycogen loading', 'Other: No Glycogen Loading']}, {'type': 'EXPERIMENTAL', 'label': 'Participants without diabetes', 'description': 'Participants with no Diabetes received Glycogen loading (GL) and Non-Glycogen loading (NGL) meal in a randomized manner.', 'interventionNames': ['Other: glycogen loading', 'Other: No Glycogen Loading']}], 'interventions': [{'name': 'glycogen loading', 'type': 'OTHER', 'description': 'Subjects will consume an isocaloric diet \\[60% carbs, 20% protein, 20% fat (33 kcal/kg/day)\\] for 3 days prior to the overnight study.', 'armGroupLabels': ['Participants without diabetes', 'Type 2 diabetes']}, {'name': 'No Glycogen Loading', 'type': 'OTHER', 'description': 'Subjects will consume an isocaloric diet \\[40% carbs, 20% protein, 40% fat (33 kcal/kg/day)\\] for 3 days prior to the overnight study.', 'armGroupLabels': ['Participants without diabetes', 'Type 2 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rita Basu', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}