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Determinants of insulin-induced weight gain in patients with type 2 diabetes mellitus, a study on liver fat content, physical activity and metabolic markers comparing weight gainers vs. non-weight gainers

Conditions
type 2 diabetes mellitus
10012653
Registration Number
NL-OMON31007
Lead Sponsor
niversitair Medisch Centrum Sint Radboud
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

· Type 2 diabetes mellitus
· Premixed insulin
· Age 20-85 years
· HbA1c < 8.5%
· Increase in body weight defined as a weight increase > 6 kg in any given period of 12 months (> 0.5 kg/months over 12 months) over a time period of 12-36 months after start of insulin therapy
· Stable body weight
· Current insulin dose >0.4 IU/kg - < 1.2 IU/kg
· Written informed consent

Exclusion Criteria

· Clinical evidence of cardiovascular or liver or other disease
· Treatment with drugs that may alter glucose tolerance, abnormal serum creatinine, macroalbuminuria, proliferative retinopathy, excessive alcohol consumption (>20 g/day), and drug abuse
· Use of thiazolidinedione derivatives (TZDs)
· Patients with pacemakers, ICD*s, implants of metal (prosthesis, (cochlear) ear implants) and patients who experience claustrophobia
· Pregnancy or intention to become pregnant during the study

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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