Insulin Detemir Action in Cerebro
Not Applicable
Completed
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT00626080
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
The aim of this study is to test the hypothesis that subcutaneous administration of insulin detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose metabolism and/or cerebral blood flow in brain regions associated with appetite regulation, to account for the reported difference in weight.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- Type 1 diabetic patients;
- Diabetes duration =/> 1 year;
- HbA1c ~ 7,5%;
Exclusion Criteria
- Recent onset of DM;
- BMI < 18 OR > 35 kg/m2;
- T2DM;
- History of major heart/renal disease;
- Severe untreated proliferative retinopathy;
- History of recurrent severe hypoglycaemia;
- (History of) brain disorders;
- Alcohol abuse,(History of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants;
- Current psychiatric disease/treatment;
- (history of) eating disorders;
- History of severe head trauma accompanied by loss of consciousness;
- Any endocrine disease not well controlled for at least 3 months;
- Inability to undergo MRI;
- Visual acuity < 0.3;
- Known or suspected allergy to trial product or related products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET After 12 weeks of treatment Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET After 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method CSF insulin concentration After 12 weeks of treatment Activity in brain regions associated with appetite control, as determined by fMRI After 12 weeks of treatment Weight change After 12 weeks of treatment
Trial Locations
- Locations (1)
VU University Medical Center
🇳🇱Amsterdam, Netherlands