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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00781495
First received: October 28, 2008
Last updated: July 11, 2011
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Weight Gain
 Device: Sensewear Bodymedia armband

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • To detect an association between insulin-induced weight gain and physical activity levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the relationship between insulin-induced weight gain and cardiovascular risk profile [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
type 2 diabetes mellitus Device: Sensewear Bodymedia armband
To assess physical activity levels patients will wear Sensewear bodymedia armband
Other Name: Sensewear Bodymedia system

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781495

Contacts
Contact: Henry Jansen, MD 0031243611111 h.jansen@aig.umcn.nl

Locations
Netherlands
Jeroen Bosch Hospital Recruiting
's-Hertogenbosch, Brabant, Netherlands, 3400 NL
Contact: Paetrick Netten, MD, PhD            
Sub-Investigator: Paetrick Netten, MD, PhD            
Jeroen Bosch Hospital Recruiting
's-Hertogenbosch, Brabant, Netherlands
Contact: Linda Kemink, MD, PhD            
Sub-Investigator: Linda Kemink, MD, PhD            
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Henry Jansen, M            
Principal Investigator: Henry Jansen, MD            
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Henry Jansen, MD Radboud University
Principal Investigator: Cees Tack, Prof.dr. Radboud University
  More Information

No publications provided

Responsible Party: Prof. dr. C. J. Tack, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00781495     History of Changes
Other Study ID Numbers: T2DM_insulin_weight gain
Study First Received: October 28, 2008
Last Updated: July 11, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
 Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013