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Insulin Detemir Action in Cerebro (INcEREBRO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626080
First Posted: February 29, 2008
Last Update Posted: December 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VU University Medical Center
  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: None (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:


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 ]
  • Cerebral blood flow, in brain regions associated with appetite control, as determined by H2O-PET [ Time Frame: After 12 weeks of treatment ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. Diamant, VU University Medical Center
ClinicalTrials.gov Identifier: NCT00626080     History of Changes
Other Study ID Numbers: DC2007Det001
2007-007255-13
First Submitted: February 19, 2008
First Posted: February 29, 2008
Last Update Posted: December 30, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs