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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Multidisciplinary program will provide the teaching and supervision necessary to integrate the new knowledge and commitment to these lifestyle changes.
EPIC Center of the Montreal Heart Institute
Montreal, Quebec, Canada
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
Time frame: 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
Time frame: at 6 months after the start of the intervention
Proportion of diabetic participants in complete remission of diabetes.
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
Time frame: 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
Time frame: at 3 and 6 months of the start of the intervention
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