Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05572502
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Reversal Online Program and Study (DROP Study)
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D000067269', 'term': 'Diet, Vegan'}], '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'}, {'id': 'D014676', 'term': 'Diet, Vegetarian'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single group, multiple replications'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated hemoglobin', 'timeFrame': '12 weeks', 'description': 'A1c will be measured before and after the study period'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': '12 weeks', 'description': 'participants will track body weight weekly using a RNFO scale'}, {'measure': 'total cholesterol', 'timeFrame': '12 weeks', 'description': 'total cholesterol will be measured before and after the study period'}, {'measure': 'LDL cholesterol', 'timeFrame': '12 weeks', 'description': 'LDL cholesterol will be measured before and after the study period'}, {'measure': 'medication usage', 'timeFrame': '12 weeks', 'description': 'changes in medications to treat diabetes will be tracked during the study period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plant-based', 'vegan', 'diet', 'obesity'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19351712', 'type': 'BACKGROUND', 'citation': 'Tonstad S, Butler T, Yan R, Fraser GE. Type of vegetarian diet, body weight, and prevalence of type 2 diabetes. Diabetes Care. 2009 May;32(5):791-6. doi: 10.2337/dc08-1886. Epub 2009 Apr 7.'}, {'pmid': '16873779', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.'}, {'type': 'BACKGROUND', 'citation': 'Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a lowfat vegetarian diet among patients with cardiac disease. J Cardiopulmonary Rehabil 1992;12:423-31.'}, {'type': 'BACKGROUND', 'citation': 'Barnard N, Scialli A, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. J Nutr Educ 2000;32:314-9.'}, {'pmid': '15286527', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35. doi: 10.1097/00008483-200407000-00004.'}, {'pmid': '19167953', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.'}, {'pmid': '12778049', 'type': 'BACKGROUND', 'citation': 'American Dietetic Association; Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian diets. J Am Diet Assoc. 2003 Jun;103(6):748-65. doi: 10.1053/jada.2003.50142.'}, {'pmid': '7842153', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Akhtar A, Nicholson A. Factors that facilitate compliance to lower fat intake. Arch Fam Med. 1995 Feb;4(2):153-8. doi: 10.1001/archfami.4.2.153.'}, {'type': 'BACKGROUND', 'citation': 'Becker M. The health belief model and personal health behavior. Health Education Monographs 1974;2:324-473.'}, {'type': 'BACKGROUND', 'citation': 'U.S. Census Bureau. Quick Facts. Internet: https://www.census.gov/quickfacts/fact/table/US/PST045221, accessed July 5, 2022.'}]}, 'descriptionModule': {'briefSummary': 'This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.', 'detailedDescription': 'This study aims to assess the feasibility and implementation of an online, plant-based, diabetes reversal program in a community setting. The study will also assess changes in glycated hemoglobin, body weight, and plasma lipids with an online 12-week, plant-based, nutrition education program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere, in addition to their value for the individual research participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states\n* Prior diagnosis of type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* Use of recreational drugs in the past 6 months\n* Pregnancy or intention to become pregnant during the study period, as verified by self-report\n* Unstable medical or psychiatric illness\n* Lack of English fluency\n* Inability to maintain current medication regimen\n* Inability or unwillingness to participate in all components of the study'}, 'identificationModule': {'nctId': 'NCT05572502', 'acronym': 'DROP', 'briefTitle': 'Diabetes Reversal Online Program and Study (DROP Study)', 'organization': {'class': 'OTHER', 'fullName': 'Physicians Committee for Responsible Medicine'}, 'officialTitle': 'The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting', 'orgStudyIdInfo': {'id': 'Pro00066361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegan diet', 'description': 'All participants will follow a low-fat vegan diet. There are no other study arms or control group.', 'interventionNames': ['Behavioral: plant-based diet']}], 'interventions': [{'name': 'plant-based diet', 'type': 'BEHAVIORAL', 'otherNames': ['vegan diet'], 'description': 'For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study', 'armGroupLabels': ['Vegan diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'VANITA RAHMAN, MD', 'role': 'CONTACT', 'email': 'vrahman@pcrm.org', 'phone': '202-527-7500'}, {'name': 'Roxanne Becker, MBChB', 'role': 'CONTACT', 'email': 'rbecker@pcrm.org', 'phone': '2022779760'}, {'name': 'Shannon Gray, RD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James Loomis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Physician Committee for Responsible Medicine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'VANITA RAHMAN, MD', 'role': 'CONTACT', 'email': 'vrahman@pcrm.org', 'phone': '2025277500'}, {'name': 'Roxanne Becker, MBChB', 'role': 'CONTACT', 'email': 'rbecker@pcrm.org', 'phone': '2022779760'}], 'overallOfficials': [{'name': 'Neal Barnard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physicians Committee for Responsible Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Physicians Committee for Responsible Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinic Director', 'investigatorFullName': 'Vanita Rahman', 'investigatorAffiliation': 'Physicians Committee for Responsible Medicine'}}}}