Clinical trial NCT02791295: Lifestyle Intervention in Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Type 2 diabetes
lifestyle intervention
insulin pump treatment
body weight
body composition
Lead sponsor: Icadom
Sponsor class: INDUSTRY
Collaborators: name: AGIR à Dom
First posted: 2016-06-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight change
timeFrame: 6 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
measure: Diabetes Treatment Satisfaction
timeFrame: 6 months
measure: Intermediate weight change
timeFrame: 3 months
measure: Retention of weight change
timeFrame: 1 year
Other outcomes:
Locations:
city: Annecy
country: France
facility: Annecy-Genevois Hospital
city: Bourgoin-Jallieu
country: France
facility: Pierre Oudot Hospital
city: Chambéry
country: France
facility: Métropole Savoie Hospital
city: Contamine-sur-Arve
country: France
facility: Alpes Léman Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Marseille
country: France
facility: Marseille European Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Anne-Laure Borel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: