Insulin Detemir Action in Cerebro

Type 1 Diabetes Clinical Trial

— INcEREBRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626080
• Other study ID #: DC2007Det001
• Secondary ID: 2007-007255-13
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: December 29, 2011
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET		After 12 weeks of treatment	No
Primary	Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET		After 12 weeks of treatment	No
Secondary	CSF insulin concentration		After 12 weeks of treatment	No
Secondary	Activity in brain regions associated with appetite control, as determined by fMRI		After 12 weeks of treatment	No
Secondary	Weight change		After 12 weeks of treatment	No