Trials / Completed
CompletedNCT02791295
Lifestyle Intervention in Type 2 Diabetes
Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Icadom · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.
Detailed description
Patients with type 2 diabetes using insulin pump therapy are gaining weight within the first months of treatment. This weight gain could counterbalance the metabolic benefice of insulin pump treatment in improving glycemic control and could lead to treatment dropout. Lifestyle intervention aiming at improving physical activity and diet in type 2 diabetes is known to brought body weight reduction and cardiometabolic improvement. The investigator hypothesized that an intensive, home-based, 6-months diet and physical activity program could prevent the body weight gain associated with insulin pump treatment initiation. The investigator will randomize patients with type 2 diabetes into a "lifestyle intervention" arm or a "usual care" control arm at the time of insulin pump treatment initiation. The primary objective will evaluate body weight change at 6 months after insulin pump treatment initiation. The secondary objectives will evaluate change in glycemic control (HbA1c) and body composition at 6 months. In addition, the retention effect will be assessed on body weight change one year after insulin pump treatment initiation, 6 months after the end of the lifestyle intervention.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Diet and physical activity program | A personalized intervention focused on improving diet and increasing physical activity will be implemented at-home with a monthly support by a registered dietician and physical activity educator during 6 months |
Timeline
- Start date
- 2016-10-04
- Primary completion
- 2021-01-19
- Completion
- 2021-03-17
- First posted
- 2016-06-06
- Last updated
- 2021-03-19
Locations
6 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02791295. Inclusion in this directory is not an endorsement.