Lifestyle Intervention in Type 2 Diabetes (WeightPump)

ICADOM Medical Center

Status

Completed

Conditions

Type 2 Diabetes Treated With Insulin

Treatments

Other: Diet and physical activity program

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02791295

2016-A00481-50

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy.
Patients addressed for the insulin pump follow-up to the home care provider supporting the study.
Public health care security affiliation.

Exclusion criteria

Breastfeeding or pregnant woman.
Not willing to participate as assessed by the investigator.
Patient engaged in another clinical trial with exclusion criteria for other protocol.
Patients unable to ride a training bike.
Unavailable in the next 6 months.
Patient without a medical certificate done in the last 12 months by a cardiologist attesting the ability to participate in a physical activity reinforcement program.