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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Radboud University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781495
First Posted: October 29, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  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:


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 ]

Secondary Outcome Measures:
  • To assess the relationship between insulin-induced weight gain and cardiovascular risk profile [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: October 28, 2008
First Posted: October 29, 2008
Last Update Posted: October 12, 2017
Last Verified: September 2009

Keywords provided by Radboud University:
insulin

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