Lifestyle Intervention in Type 2 Diabetes

Type 2 Diabetes Treated With Insulin Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791295
• Other study ID #: 2016-A00481-50
• Status: Completed
• Phase: N/A
• Start date: October 4, 2016
• Est. completion date: March 17, 2021

Study information

• Verified date: March 2021
• Source: Icadom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 17, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

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

Locations

Country	Name	City	State
France	Annecy-Genevois Hospital	Annecy
France	Pierre Oudot Hospital	Bourgoin-Jallieu
France	Métropole Savoie Hospital	Chambéry
France	Alpes Léman Hospital	Contamine-sur-Arve
France	Grenoble University Hospital	Grenoble
France	Marseille European Hospital	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Icadom	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.	6 months
Secondary	Glycemic control	The difference in HbA1c changes between the two groups after 6-months of insulin pump treatment initiation.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Intermediate weight change	The difference in weight changes between the two groups after 3-months of insulin pump treatment initiation.	3 months
Secondary	Retention of weight change	The difference in weight changes between the two groups at 12-months of insulin pump treatment initiation.	1 year