Insulin Detemir Action in Cerebro (INcEREBRO)

December 29, 2011 updated by: Amsterdam UMC, location VUmc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
CSF insulin concentration
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
Activity in brain regions associated with appetite control, as determined by fMRI
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment
Weight change
Time Frame: After 12 weeks of treatment
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Michaela Diamant, MD, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2011

Last Update Submitted That Met QC Criteria

December 29, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC2007Det001
  • 2007-007255-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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