Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
NCT ID: NCT00781495
Last Updated: 2011-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2008-12-31
2011-12-31
Brief Summary
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Primary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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type 2 diabetes mellitus
Sensewear Bodymedia armband
To assess physical activity levels patients will wear Sensewear bodymedia armband
Interventions
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Sensewear Bodymedia armband
To assess physical activity levels patients will wear Sensewear bodymedia armband
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-85 years
* Hba1c at baseline \< 12.0%
* written informed consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Radboud University Nijmegen Medical Centre
Principal Investigators
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Henry Jansen, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Cees Tack, Prof.dr.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Henry Jansen, M
Role: primary
Paetrick Netten, MD, PhD
Role: primary
Linda Kemink, MD, PhD
Role: primary
References
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Jansen HJ, Stienstra R, van Diepen JA, Hijmans A, van der Laak JA, Vervoort GM, Tack CJ. Start of insulin therapy in patients with type 2 diabetes mellitus promotes the influx of macrophages into subcutaneous adipose tissue. Diabetologia. 2013 Dec;56(12):2573-81. doi: 10.1007/s00125-013-3018-6. Epub 2013 Sep 25.
Other Identifiers
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T2DM_insulin_weight gain
Identifier Type: -
Identifier Source: org_study_id
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