Insulin Detemir Action in Cerebro

Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes

Sponsors

Lead Sponsor: VU University Medical Center

Source VU University Medical Center
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.

Overall Status Completed
Start Date January 2009
Completion Date December 2011
Primary Completion Date December 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin detemir

Description: 100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

Other Name: Insulin Levemir

Intervention Type: Drug

Intervention Name: Insulin NPH

Description: 100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

Other Name: Insulin Insulatard

Eligibility

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michaela Diamant, MD, PhD Principal Investigator VU University Medical Center
Location
Facility: VU University Medical Center
Location Countries

Netherlands

Verification Date

December 2011

Responsible Party

Name Title: M. Diamant

Organization: VU University Medical Center

Keywords
Has Expanded Access No
Condition Browse
Acronym INcEREBRO
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov