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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00781495
• Other study ID #: T2DM_insulin_weight gain
• Status: Unknown status
• Phase: N/A
• First received: October 28, 2008
• Last updated: July 11, 2011
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2009
• Source: Radboud University
• Contact: Henry Jansen, MD
• Phone: 0031243611111
• Email: h.jansen[@]aig.umcn.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 75
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus
• Weight Gain

Intervention

Device:
• Sensewear Bodymedia armband
To assess physical activity levels patients will wear Sensewear bodymedia armband

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	's-Hertogenbosch	Brabant
Netherlands	Jeroen Bosch Hospital	's-Hertogenbosch	Brabant
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detect an association between insulin-induced weight gain and physical activity levels		1 year
Secondary	To assess the relationship between insulin-induced weight gain and cardiovascular risk profile		1 year