Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-28 @ 10:33 PM
Study NCT ID:
NCT05495451
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], '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': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The randomisation will be effectuated with the participant number only for the Intermittent Fasting Intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '36 participants will be taught to follow the Mediterranean diet (40% carbohydrates) and training 3 times a week (HIIT and weight training) for 3 months. At 3 months, there will be a randomization: 12 participants will continue the same interventions while 24 will add Intermittent Fasting Intervention for 3 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-19', 'studyFirstSubmitDate': '2022-03-14', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.', 'timeFrame': 'at 3 months after the start of the intervention', 'description': 'Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention'}, {'measure': 'Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.', 'timeFrame': 'at 6 months after the start of the intervention', 'description': 'Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention'}], 'secondaryOutcomes': [{'measure': 'Proportion of diabetic participants in complete remission of diabetes.', 'timeFrame': 'at 3 and 6 months of the start of the intervention', 'description': 'Remission of diabetes will be defined by the following 3 criteria:\n\n1. An HbA1c \\< 6,5% at 3 months of intervention (Metabolic criteria)\n2. Which is maintained at 6 months (Duration criteria)\n3. Without the use of glucose-lowering agents (Pharmacological criteria)\n\nProportion of prediabetic patients that reach an Hb1Ac \\< 6,5% at 6 months of intervention will also be studied'}, {'measure': 'Evolution of the HOMA-IR between the start of the program, the middle of the intervention (3 months) and the end of the intervention (6 months).', 'timeFrame': 'at 3 and 6 months of the start of the intervention', 'description': 'HOMA-IR is a marker of insulin resistance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/29221645', 'label': 'Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, Mccombie L, et al.. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. The Lancet 2018;391:541-51. doi:10.1016/s0140-6736(17)33102-1.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/31097391', 'label': 'Taylor R, Al-Mrabeh A, Sattar N. Understanding the mechanisms of reversal of type 2 diabetes. Lancet Diabetes Endocrinol. 2019 Sep;7(9):726-736.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/32060017', 'label': 'Zhyzhneuskaya SV, Al-Mrabeh A, Peters C et al. Time Course of Normalization of Functional β-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes. Diabetes Care 2020;43:813-2'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30642190', 'label': 'Kemps H, Kränkel N, Dörr M et al.. Exercise training for patients with type 2 diabetes and cardiovascular disease: What to pursue and how to do it. A Position Paper of the European Association of Preventive Cardiology'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/31881139', 'label': 'de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.', 'detailedDescription': "The morbidities associated with type 2 diabetes (Db2) are major, including cardiovascular and renal complications, but also cognitive impairment. Providing interventions targeting Db2 reversal has shown great potential to improve healthy aging.\n\nA Db2 reversal clinic has been established at the Montreal Heart Institute's ÉPIC Center, with an approach based on the Mediterranean diet and exercise. First-year results showed a 0.6% decrease in Hb1Ac and an average weight loss at 3 months of 4.5 kg in diabetic patients. This improvement was maintained at 6 and 12 months. Although these results are encouraging, the literature in Db2 remission shows that a weight loss of 10 kg is the ideal goal.\n\nTherefore, to offer the possibility of further metabolic improvement at 6 months, three interventions are proposed as additions to the current program: targeting ultra-processed food reduction, motivational coaching and intermittent fasting. The main objective of our pilot study is to determine the feasibility of this improved program in type 2 diabetic patients, aged 18 to 80 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home.\n\nExclusion Criteria:\n\n* All types of diabetes other than type 2\n* Taking the following glucose-lowering agents: insulin, sulfonylureas\n* BMI \\< 18,5 kg/m2\n* Unintentional weight loss of more than 10 kg in the past year\n* Moderate to severe retinopathy\n* Pregnant or nursing woman\n* Severe organ failure\n* Pathologies predisposing to gastrointestinal bleeding, untreated\n* Recent cholecystitis (3 months)\n* Antibiotic use in the past 3 months, or untreated active infection\n* Known impaired nutrient absorption\n* Uninvestigated new anemia or Hb \\< 110 g/100 mL\n* Currently following an intermittent or prolonged fasting protocol\n* Currently following a specific diet (vegan, celiac/gluten free, ketogenic)\n* Active diagnoses of psychiatric or neurological illness not controlled for at least 6 months\n* Taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.'}, 'identificationModule': {'nctId': 'NCT05495451', 'acronym': 'DIABEPIC2', 'briefTitle': 'Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal', 'orgStudyIdInfo': {'id': 'ICM 2022-3018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean diet and Personalized training', 'description': '36 participants will participate to the following lifestyle changes for 6 months:\n\nBehavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet.\n\nPersonalized exercise prescription and training (3 times per week)\n\nPersonalized education and motivational interviewing', 'interventionNames': ['Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent Fasting Intervention', 'description': 'Between 3 and 6 months, 24 participants (on a total of 36) will progressively integrate intermittent fasting 16:8 (5 times/week for 12 weeks) and 20:4 (2 times/week for 4 weeks)', 'interventionNames': ['Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting']}], 'interventions': [{'name': 'Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting', 'type': 'BEHAVIORAL', 'description': 'Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.', 'armGroupLabels': ['Intermittent Fasting Intervention', 'Mediterranean diet and Personalized training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 1N6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'EPIC Center of the Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'One year after completion of the study', 'ipdSharing': 'YES', 'description': 'If the sponsor accepts, we would agree with making individual date available to other researchers', 'accessCriteria': 'Upon request to the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Centre EPIC research lab', 'investigatorFullName': 'Louis Bherer', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}