Lifestyle Intervention in Type 2 Diabetes (WeightPump)

March 17, 2021 updated by: Icadom

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France, 74370
        • Annecy-Genevois Hospital
      • Bourgoin-Jallieu, France, 38302
        • Pierre Oudot Hospital
      • Chambéry, France, 73000
        • Métropole Savoie Hospital
      • Contamine-sur-Arve, France, 74130
        • Alpes Léman Hospital
      • Grenoble, France, 38043
        • Grenoble University Hospital
      • Marseille, France, 13003
        • Marseille European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
standard care
Experimental: Diet and physical activity program
Diet and physical activity program with individual coaching
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 6 months
The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.
6 months
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.
6 months
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.
6 months
Intermediate weight change
Time Frame: 3 months
The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.
3 months
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icadom

Collaborators

AGIR à Dom

Investigators

  • Principal Investigator: Anne-Laure Borel, MD PhD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

March 17, 2021

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00481-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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