Type 2 Diabetes
Conditions
Keywords
Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes
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.
Interventions
BEHAVIORALModerate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting
Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.
Sponsors
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The randomisation will be effectuated with the participant number only for the Intermittent Fasting Intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes. | at 3 months after the start of the intervention | Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 studied |
| 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). | at 3 and 6 months of the start of the intervention | HOMA-IR is a marker of insulin resistance |
Countries
Canada
Outcome results
None listed