Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes 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. Exclusion Criteria: All types of diabetes other than type 2 Taking the following glucose-lowering agents: insulin, sulfonylureas BMI < 18,5 kg/m2 Unintentional weight loss of more than 10 kg in the past year Moderate to severe retinopathy Pregnant or nursing woman Severe organ failure Pathologies predisposing to gastrointestinal bleeding, untreated Recent cholecystitis (3 months) Antibiotic use in the past 3 months, or untreated active infection Known impaired nutrient absorption Uninvestigated new anemia or Hb < 110 g/100 mL Currently following an intermittent or prolonged fasting protocol Currently following a specific diet (vegan, celiac/gluten free, ketogenic) Active diagnoses of psychiatric or neurological illness not controlled for at least 6 months Taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet and Personalized training<br>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 | Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting<br>* Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.<br>|
| Active Comparator: Intermittent Fasting Intervention<br>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) | Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting<br>* Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of diabetic participants in complete remission of diabetes. | Remission of diabetes will be defined by the following 3 criteria: An HbA1c < 6,5% at 3 months of intervention (Metabolic criteria) Which is maintained at 6 months (Duration criteria) Without the use of glucose-lowering agents (Pharmacological criteria) Proportion of prediabetic patients that reach an Hb1Ac < 6,5% at 6 months of intervention will also be studied | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes