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Insulin Detemir Action in Cerebro (INcEREBRO)

This study has been completed.
Sponsor:
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00626080
First received: February 19, 2008
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Drug: Insulin detemir
Drug: Insulin NPH

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effects of INsulin dEtemiR and Neutral protaminE Hagedorn (NPH) Insulin on BRain glucOse Metabolism: a Study in Persons With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CSF insulin concentration [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Activity in brain regions associated with appetite control, as determined by fMRI [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Weight change [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: Insulin Levemir
    Drug: Insulin NPH
    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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626080

Locations
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
Investigators
Principal Investigator: Michaela Diamant, MD, PhD VU University Medical Center
  More Information

No publications provided

Responsible Party: M. Diamant, VU University Medical Center
ClinicalTrials.gov Identifier: NCT00626080     History of Changes
Other Study ID Numbers: DC2007Det001, 2007-007255-13
Study First Received: February 19, 2008
Last Updated: December 29, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Insulin
Detemir
Brain
Glucose metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013