Trials / Completed
CompletedNCT05495451
Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Montreal Heart Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Moderate-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. |
Timeline
- Start date
- 2022-01-21
- Primary completion
- 2023-03-21
- Completion
- 2023-05-21
- First posted
- 2022-08-10
- Last updated
- 2023-11-21
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05495451. Inclusion in this directory is not an endorsement.