Clinical trial NCT00781495: Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
Official title: Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Weight Gain
Keywords: insulin
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-10-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: To detect an association between insulin-induced weight gain and physical activity levels
timeFrame: 1 year
Secondary outcomes:
measure: To assess the relationship between insulin-induced weight gain and cardiovascular risk profile
timeFrame: 1 year
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: Brabant
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: Brabant
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Henry Jansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Cees Tack, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.