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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by VU University Medical Center

Additional 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
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014