Clinical trial NCT05495451: Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
Official title: Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Mediterranean Diet, Intermittent Fasting, Training, Lifestyle Changes
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.
timeFrame: at 3 months after the start of the intervention
measure: Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.
timeFrame: at 6 months after the start of the intervention
Secondary outcomes:
measure: Proportion of diabetic participants in complete remission of diabetes.
timeFrame: at 3 and 6 months of the start of the intervention
measure: 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).
timeFrame: at 3 and 6 months of the start of the intervention
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: EPIC Center of the Montreal Heart Institute
state: Quebec
Study officials:
References: