Insulin Detemir Action in Cerebro - Full Text View

Sponsored by:	VU University Medical Center
Information provided by:	VU University Medical Center
ClinicalTrials.gov Identifier:	NCT00626080

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

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin Detemir Dextrose Insulin, isophane Protamine

U.S. FDA Resources

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

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
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

100 IU/ml, QD, dose individually adjusted, to be used for a period of 12 weeks; in combination with insulin aspart TID

Eligibility

Ages Eligible for Study:	24 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetic patients;
Diabetes duration =/> 5 years;
HbA1c max 7,5%;
Right-handed

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

Contacts

Contact: Michaela Diamant, MD, PhD	+31-20-4440533	m.diamant@vumc.nl
Contact: Larissa W van Golen, MD	+31-20-4442758	l.vangolen@vumc.nl

Locations

Netherlands
VU University Medical Center	Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Michaela Diamant, MD, PhD +31-20-4440533 m.diamant@vumc.nl

Sponsors and Collaborators

VU University Medical Center

Investigators

Principal Investigator:

Michaela Diamant, MD, PhD

VU University Medical Center

More Information

Responsible Party:	VU University Medical Center ( M. Diamant )
Study ID Numbers:	DC2007Det001, 2007-007255-13
Study First Received:	February 19, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00626080
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:

Insulin
Detemir
Brain
Glucose metabolism

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Protamines
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009