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

July 11, 2011 updated by: Radboud University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

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

  • Netherlands
    • Brabant
      • 's-Hertogenbosch, Brabant, Netherlands, 3400 NL
        • Recruiting
        • Jeroen Bosch Hospital
        • Contact:
          • Paetrick Netten, MD, PhD
        • Sub-Investigator:
          • Paetrick Netten, MD, PhD
      • 's-Hertogenbosch, Brabant, Netherlands
        • Recruiting
        • Jeroen Bosch Hospital
        • Contact:
          • Linda Kemink, MD, PhD
        • Sub-Investigator:
          • Linda Kemink, MD, PhD
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Recruiting
        • Radboud University Nijmegen Medical Centre
        • Contact:
          • Henry Jansen, M
        • Principal Investigator:
          • Henry Jansen, MD

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with type 2 diabetes mellitus, selected from the out-patient clinic of the Radboud University Nijmegen Medical Centre and four other non-academic hospitals.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
type 2 diabetes mellitus
Device: Sensewear Bodymedia armband
To assess physical activity levels patients will wear Sensewear bodymedia armband
Other Names:
  • Sensewear Bodymedia system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To detect an association between insulin-induced weight gain and physical activity levels
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the relationship between insulin-induced weight gain and cardiovascular risk profile
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Henry Jansen, MD, Radboud University Medical Center
  • Principal Investigator: Cees Tack, Prof.dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2008

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2DM_insulin_weight gain

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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