Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-09 @ 9:56 AM
Study NCT ID:
NCT03832933
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2019-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073600', 'term': 'Diet, High-Protein'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-07', 'studyFirstSubmitDate': '2019-02-05', 'studyFirstSubmitQcDate': '2019-02-05', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight by weight scale', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Participant body weights will be measured on a kg scale'}, {'measure': 'Change in body weight by weight scale', 'timeFrame': 'Baseline to 52 weeks', 'description': 'Participant body weights will be measured on a kg scale'}], 'secondaryOutcomes': [{'measure': 'Change in T2D diagnosis criteria', 'timeFrame': 'Baseline to 52 weeks.', 'description': 'T2D diagnosis will be determined according to American Diabetes Association criteria, which includes fasting glucose \\<126 mg/dL or hemoglobin A1c \\<6.5%.'}, {'measure': 'Change in % body fat', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.'}, {'measure': 'Change in % body fat', 'timeFrame': 'Baseline to 52 weeks.', 'description': 'Participant body fat will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.'}, {'measure': 'Change in % fat free mass (FFM)', 'timeFrame': 'Baseline to 16 weeks.', 'description': 'Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.'}, {'measure': 'Change in % FFM', 'timeFrame': 'Baseline to 52 weeks.', 'description': 'Participant FFM will be measured by dual x-ray absorptiometry (DXA), which is the gold standard for measuring body composition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['weight loss', 'dietary protein'], 'conditions': ['Diabetes Type 2', 'Obesity', 'Diet Modification']}, 'referencesModule': {'references': [{'pmid': '37475689', 'type': 'DERIVED', 'citation': 'Clina JG, Sayer RD, Pan Z, Cohen CW, McDermott MT, Catenacci VA, Wyatt HR, Hill JO. High- and normal-protein diets improve body composition and glucose control in adults with type 2 diabetes: a randomized trial. Obesity (Silver Spring). 2023 Aug;31(8):2021-2030. doi: 10.1002/oby.23815.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the impact of high protein (HP) vs. normal protein (NP) diets on weight loss, loss of fat free mass (FFM), and remission of type 2 diabetes (T2D) in individuals with T2D. Both diet groups will receive dietary and physical activity guidance through a group-based weight loss program, State of Slim (SOS). The central hypothesis is that the HP diet (with ≥4 weekly servings of lean beef) will lead to greater remission of T2D vs. a NP diet by 1) producing greater weight loss and limiting weight regain and 2) preferentially reducing fat mass while preserving FFM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Age ≥18 years\n* T2D diagnosis within previous 6 years (documented physician diagnosis, use of antidiabetic medication, fasting glucose ≥126 mg/dl, and/or HbA1c ≥6.5%)\n* BMI of ≥27 kg/m2\n* Weight stable (±3kg in the last 3 months)\n* Participants using GLP-1 agonists or SLGT-inhibitors must be on a stable (≥3 months) medication dosage and not be planning to change medication dosage\n* Willing and able to participate in a weekly group class for the first 16 weeks of the study, bi-weekly classes for the remainder of the study, and willing to participate in 4 study visits over the 52 week study period.\n\nExclusion Criteria:\n\n* HbA1c concentration of ≥12%.\n* Pregnant or lactating within the past 6 months or trying to become pregnant.\n* Individuals following a vegetarian/vegan only diet\n* Food allergies (to red meats or other common protein sources)\n* Using exogenous insulin for T2D management\n* Taking other medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals that do not have a weight effect are allowed as long as use is continued without change during the study.\n* Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).\n* Current Eating disorder (anorexia or bulimia)\n* Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable.\n* Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.'}, 'identificationModule': {'nctId': 'NCT03832933', 'briefTitle': 'Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Comparing High and Normal Protein Diets for the Dietary Remission of Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IRB-300002928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Protein Diet', 'interventionNames': ['Behavioral: High Protein Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Protein Diet', 'interventionNames': ['Behavioral: Standard Protein Diet']}], 'interventions': [{'name': 'High Protein Diet', 'type': 'BEHAVIORAL', 'description': '16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.', 'armGroupLabels': ['High Protein Diet']}, {'name': 'Standard Protein Diet', 'type': 'BEHAVIORAL', 'description': '16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.', 'armGroupLabels': ['Standard Protein Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'James Hill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'James O. Hill', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}