Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal (DIABEPIC2)

University of Montreal

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT05495451

ICM 2022-3018

Details and patient eligibility

About

To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Mediterranean diet and Personalized training

Experimental group

Description:

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

Treatment:

Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting

Intermittent Fasting Intervention

Active Comparator group

Description:

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)

Treatment:

Behavioral: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting