Status:
COMPLETED
Insulin Detemir Action in Cerebro
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Type 1 Diabetes
Eligibility:
MALE
18-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Type 1 diabetic patients;
- Diabetes duration =/\> 1 year;
- HbA1c \~ 7,5%;
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00626080
Start Date
January 1 2009
End Date
December 1 2011
Last Update
December 30 2011
Active Locations (1)
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1
VU University Medical Center
Amsterdam, Netherlands, 1081 HV