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Lifestyle Intervention in Type 2 Diabetes (WeightPump)

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diet and physical activity program
Sponsored by
Icadom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Treated With Insulin focused on measuring Type 2 diabetes, lifestyle intervention, insulin pump treatment, body weight, body composition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Annecy-Genevois Hospital
  • Pierre Oudot Hospital
  • Métropole Savoie Hospital
  • Alpes Léman Hospital
  • Grenoble University Hospital
  • Marseille European Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet and physical activity program

control

Arm Description

Diet and physical activity program with individual coaching

standard care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glycemic control
The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.
Body composition
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.
Diabetes Treatment Satisfaction
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
The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.
Retention of weight change
The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.

Full Information

First Posted
June 1, 2016
Last Updated
March 17, 2021
Sponsor
Icadom
Collaborators
AGIR à Dom
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1. Study Identification

Unique Protocol Identification Number
NCT02791295
Brief Title
Lifestyle Intervention in Type 2 Diabetes
Acronym
WeightPump
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
March 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icadom
Collaborators
AGIR à Dom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin
Keywords
Type 2 diabetes, lifestyle intervention, insulin pump treatment, body weight, body composition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet and physical activity program
Arm Type
Experimental
Arm Description
Diet and physical activity program with individual coaching
Arm Title
control
Arm Type
No Intervention
Arm Description
standard care
Intervention Type
Other
Intervention Name(s)
Diet and physical activity program
Intervention Description
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 Outcome Measure Information:
Title
Weight change
Description
The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glycemic control
Description
The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.
Time Frame
6 months
Title
Body composition
Description
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.
Time Frame
6 months
Title
Diabetes Treatment Satisfaction
Description
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.
Time Frame
6 months
Title
Intermediate weight change
Description
The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.
Time Frame
3 months
Title
Retention of weight change
Description
The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Laure Borel, MD PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annecy-Genevois Hospital
City
Annecy
ZIP/Postal Code
74370
Country
France
Facility Name
Pierre Oudot Hospital
City
Bourgoin-Jallieu
ZIP/Postal Code
38302
Country
France
Facility Name
Métropole Savoie Hospital
City
Chambéry
ZIP/Postal Code
73000
Country
France
Facility Name
Alpes Léman Hospital
City
Contamine-sur-Arve
ZIP/Postal Code
74130
Country
France
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Marseille European Hospital
City
Marseille
ZIP/Postal Code
13003
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lifestyle Intervention in Type 2 Diabetes

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