Skip to main content
OpenTrials
Completed

NCT Number: NCT02791295

Lifestyle Intervention in Type 2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Annecy-Genevois Hospital, Annecy, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet and physical activity program

Other

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

Primary outcomes

  1. Weight change

    Time frame: 6 months

    The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.

Secondary outcomes

  1. Glycemic control

    Time frame: 6 months

    The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.

  2. Body composition

    Time frame: 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.

  3. Diabetes Treatment Satisfaction

    Time frame: 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.

  4. Intermediate weight change

    Time frame: 3 months

    The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.

  5. Retention of weight change

    Time frame: 1 year

    The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.

Sponsors and collaborators

Lead sponsor

Icadom

Industry

Collaborators

  • AGIR à Dom

Registry information

Official study 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

Acronym: WeightPump

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2016
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.