Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
- Conditions
- Type 2 Diabetes
- Interventions
- Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting
- Registration Number
- NCT05495451
- Lead Sponsor
- Montreal Heart Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediterranean diet and Personalized training Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting 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 Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting 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)
- Primary Outcome Measures
Name Time Method Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes. at 6 months after the start of the intervention Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention
- Secondary Outcome Measures
Name Time Method Proportion of diabetic participants in complete remission of diabetes. at 3 and 6 months of the start of the intervention Remission of diabetes will be defined by the following 3 criteria:
1. An HbA1c \< 6,5% at 3 months of intervention (Metabolic criteria)
2. Which is maintained at 6 months (Duration criteria)
3. 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 studiedEvolution 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). at 3 and 6 months of the start of the intervention HOMA-IR is a marker of insulin resistance
Trial Locations
- Locations (1)
EPIC Center of the Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada