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Insulin Detemir Action in Cerebro (INcEREBRO)

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ClinicalTrials.gov Identifier: NCT00626080
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : December 30, 2011
Sponsor:
Information provided by:
VU University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Insulin detemir Drug: Insulin NPH Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Cerebral metabolic rate of glucose, in brain regions associated with appetite control, as determined by FDG-PET [ Time Frame: After 12 weeks of treatment ]
  2. 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 :
  1. CSF insulin concentration [ Time Frame: After 12 weeks of treatment ]
  2. Activity in brain regions associated with appetite control, as determined by fMRI [ Time Frame: After 12 weeks of treatment ]
  3. Weight change [ Time Frame: After 12 weeks of treatment ]


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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

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

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 Posted: February 29, 2008    Key Record Dates
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