Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT00607867
Status:
TERMINATED
Last Update Posted:
2014-12-12
First Post:
2008-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
LoBAG30 Diet in Patients on Metformin
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': 'ganno004@umn.edu', 'phone': '6124672895', 'title': 'Mary C. Gannon, Ph.D.', 'organization': 'Minneapolis VA Health Care System, Metabolic Research Labortory'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Funding ended with only 14 subjects studied. With a parallel arm design, we were not able to draw any conclusions from the study. Funds were unavailable for a more sophisticated statistical analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.\n\nLoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.\n\nControl Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in %Hemoglobin A1c at 5 Weeks From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'OG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 5 weeks after dietary intervention', 'description': 'Hemoglobin A1c measured before and after 5 weeks on the diet', 'unitOfMeasure': 'Change in % A1c at 5 weeks from baseli', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Microalbumin Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'OG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Total Glucose Area at 5 Weeks From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'OG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'classes': [{'categories': [{'measurements': [{'value': '-957', 'spread': '302', 'groupId': 'OG000'}, {'value': '-691', 'spread': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 5 weeks after dietary intervention', 'description': 'The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.', 'unitOfMeasure': 'mg hr/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Body Weight at 5 Weeks From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'OG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'OG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'classes': [{'categories': [{'measurements': [{'value': '-22', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '-33', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Triglycerides at 5 Weeks From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'OG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'classes': [{'categories': [{'measurements': [{'value': '-18', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '-24', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat'}, {'id': 'FG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet 55% CHO, 15% protein, 30% fat'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Proposed study design was 20 subjects, 10/arm. (Parallel arm design requested by grant Reviewers.) At the end of the funding period, 14 subjects had been enrolled and studied, 7 in each arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LoBAG30 Diet', 'description': 'A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.'}, {'id': 'BG001', 'title': 'Control Diet', 'description': 'A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '71'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '66'}, {'value': '61.6', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects with type 2 diabetes being treated with metformin'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'The funding ended before the study was completed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-10', 'studyFirstSubmitDate': '2008-01-31', 'resultsFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2008-02-05', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-10', 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in %Hemoglobin A1c at 5 Weeks From Baseline', 'timeFrame': 'Baseline and 5 weeks after dietary intervention', 'description': 'Hemoglobin A1c measured before and after 5 weeks on the diet'}, {'measure': 'Change in Total Glucose Area at 5 Weeks From Baseline', 'timeFrame': 'Baseline and 5 weeks after dietary intervention', 'description': 'The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.'}, {'measure': 'Change in Body Weight at 5 Weeks From Baseline', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.'}, {'measure': 'Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.'}], 'secondaryOutcomes': [{'measure': 'Microalbumin Excretion', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention'}, {'measure': 'Change in Fasting Triglycerides at 5 Weeks From Baseline', 'timeFrame': 'baseline and 5 weeks after dietary intervention', 'description': 'Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus (type 2)', 'Diet', 'Glycohemoglobin', 'Lipids', 'Kidney Function', 'Glycemic Index', 'Dietary Protein', 'Dietary Carbohydrate'], 'conditions': ['Diabetes Mellitus', 'Diet']}, 'descriptionModule': {'briefSummary': 'We will determine the metabolic response to a Low Biologically Available Glucose Diet (LoBAG30) in subjects currently receiving the maximum dose of metformin as monotherapy in whom the glycohemoglobin is not at an acceptable level (\\>8.0%). Our hypothesis is that introduction of a LoBAG30 diet to subjects currently treated with a full therapeutic dose of metformin will improve blood glucose control in people who have not achieved an acceptable total glycohemoglobin on metformin alone.', 'detailedDescription': 'Subjects will ingest a control diet (55% carbohydrate (CHO), 15% protein, 30% fat) or a LoBAG30 diet (30% CHO, 30% protein, 40% fat) in a parallel design with block randomization in pairs of two. Subjects will return to the study center twice each week while on the diets to have blood glucose, glycohemoglobin, lactate, weight and blood pressure measured, and to have urine assayed for urea and creatinine. At the beginning and end of the 5 week study period, the subjects will be admitted to the study center for 28 hours during which time blood will be drawn for 24 hour profiles of glucose, insulin, other hormones and several metabolites. For those subjects randomized to the LoBAG30 arm of the study, the control diet will be given during the first 24 hour study period; the assigned diet will be given at the end of the 5 week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with type 2 diabetes mellitus who currently are receiving the maximal dose of metformin monotherapy (2500 mg/day).\n* These subjects will have had a stable glycohemoglobin (tGHb) in an unacceptably high range (8-11%) for at least 4 months prior to beginning the study.\n* Subjects with tGHB \\> 11% (HbA1c \\> 10%) will not be recruited into the study.\n\nExclusion Criteria:\n\n* Hematological abnormalities\n* liver disease\n* kidney disease\n* macroalbuminuria (\\>300 mg albumin/24 hours)\n* untreated thyroid disease\n* congestive heart failure\n* angina\n* life-threatening malignancies\n* proliferative retinopathy\n* severe diabetic neuropathy\n* peripheral vascular disease\n* serious psychological disorders\n* a body mass index \\> 35\n* and a fasting triglyceride of \\>400 mg/dl.\n\n * Subjects taking slow-release metformin will not be studied.\n * Subjects taking medications other than metformin, known to affect fuel metabolism such as:\n* insulin\n* the sulfonylureas\n* glucagon-like peptide 1 (GLP-1) analogs and metabolic inhibitors\n* pramlintide\n* prednisone and similar steroids\n* thyroid hormone\n* antipsychotic medications\n* thiazide diuretics\n* medroxyprogesterone\n* high dose aspirin, also will be excluded.\n\n * If concentrations of serum folate, B12 or iron are low, the subject will be excluded from the study until corrected, i.e. until normal concentrations are recorded.'}, 'identificationModule': {'nctId': 'NCT00607867', 'acronym': 'LoBAG Diet', 'briefTitle': 'LoBAG30 Diet in Patients on Metformin', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Metabolic Response to a LoBAG30 Diet in Diabetic Patients on Metformin', 'orgStudyIdInfo': {'id': 'CLIN-010-07F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.', 'interventionNames': ['Other: LoBAG30 diet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.', 'interventionNames': ['Other: Control Diet']}], 'interventions': [{'name': 'LoBAG30 diet', 'type': 'OTHER', 'description': 'A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat.', 'armGroupLabels': ['Arm 1']}, {'name': 'Control Diet', 'type': 'OTHER', 'description': 'A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'VA Medical Center, Minneapolis', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Mary Gannon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}