Lifestyle Intervention in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Treated With Insulin
• Interventions: Other: Diet and physical activity program

• Registration Number: NCT02791295
• Lead Sponsor: Icadom

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.

Study Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-06
• Study Start: 2016-10-04
• Primary Completion: 2021-01-19
• Status Verified: 2021-03
• Study Completion: 2021-03-17
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and physical activity program	Diet and physical activity program	Diet and physical activity program with individual coaching

Primary Outcome Measures

Name	Time	Method
Weight change	6 months	The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.

Secondary Outcome Measures

Name	Time	Method
Body composition	6 months	The difference between the two groups in distribution of fat mass and lean mass between the first visit and 6 months after initiation of insulin pump treatment.
Retention of weight change	1 year	The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.
Glycemic control	6 months	The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.
Diabetes Treatment Satisfaction	6 months	The difference between the two groups of scores of the Diabetes Treatment Satisfaction Questionnaire between the first visit and 6 months after initiation of insulin pump treatment.
Intermediate weight change	3 months	The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.

Trial Locations

Locations (6)

Alpes Léman Hospital; 🇫🇷 Contamine-sur-Arve, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

Métropole Savoie Hospital; 🇫🇷 Chambéry, France

Pierre Oudot Hospital; 🇫🇷 Bourgoin-Jallieu, France

Annecy-Genevois Hospital; 🇫🇷 Annecy, France

Marseille European Hospital; 🇫🇷 Marseille, France