Insulin Detemir Action in Cerebro
Information source: VU University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Insulin detemir (Drug); Insulin NPH (Drug)
Phase: N/A
Status: Completed
Sponsored by: VU University Medical Center Official(s) and/or principal investigator(s): Michaela Diamant, MD, PhD, Principal Investigator, Affiliation: VU University Medical Center
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.
Clinical Details
Official title: Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PETCerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET
Secondary outcome: CSF insulin concentrationActivity in brain regions associated with appetite control, as determined by fMRI Weight change
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
VU University Medical Center, Amsterdam 1081 HV, Netherlands
Additional Information
Starting date: January 2009
Last updated: December 29, 2011
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