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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-PET

Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET

Secondary outcome:

CSF insulin concentration

Activity 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

Page last updated: August 23, 2015

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