Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus

• Conditions: Type 2 Diabetes Mellitus; Weight Gain
• Interventions: Device: Sensewear Bodymedia armband

• Registration Number: NCT00781495
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus

Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.

Detailed Description

Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus.

The aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain

Study Timeline

• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Study Start: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2011-07-11
• Last Update Posted: 2011-07-12
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• patients with type 2 diabetes mellitus
• age 18-85 years
• Hba1c at baseline < 12.0%
• written informed consent

Exclusion Criteria

• Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight
• Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels
• Excessive alcohol consumption (>20 g/day), and drug abuse
• Use of thiazolidinedione derivatives (TZDs)
• Pregnancy or intention to become pregnant during the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 2 diabetes mellitus	Sensewear Bodymedia armband	-

Primary Outcome Measures

Name	Time	Method
To detect an association between insulin-induced weight gain and physical activity levels	1 year

Secondary Outcome Measures

Name	Time	Method
To assess the relationship between insulin-induced weight gain and cardiovascular risk profile	1 year

Trial Locations

Locations (2)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands

Jeroen Bosch Hospital; 🇳🇱 's-Hertogenbosch, Brabant, Netherlands