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To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.
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.
A 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.
Therefore, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet and Personalized training | Experimental | 36 participants will participate to the following lifestyle changes for 6 months: Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet. Personalized exercise prescription and training (3 times per week) Personalized education and motivational interviewing |
|
| Intermittent Fasting Intervention | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting | Behavioral | Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes. | Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention | at 3 months after the start of the intervention |
| Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes. | Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention | at 6 months after the start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of diabetic participants in complete remission of diabetes. | Remission of diabetes will be defined by the following 3 criteria:
Proportion of prediabetic patients that reach an Hb1Ac < 6,5% at 6 months of intervention will also be studied |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPIC Center of the Montreal Heart Institute | Montreal | Quebec | H1T 1N6 | Canada |
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| Label | URL |
|---|---|
| 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. | View source |
| 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. | View source |
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If the sponsor accepts, we would agree with making individual date available to other researchers
One year after completion of the study
Upon request to the principal investigator
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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The randomisation will be effectuated with the participant number only for the Intermittent Fasting Intervention.
| at 3 and 6 months of the start of the intervention |
| 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). | HOMA-IR is a marker of insulin resistance | at 3 and 6 months of the start of the intervention |
| 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 | View source |
| 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 | View source |
| 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 | View source |
| D004700 | Endocrine System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |