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Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00638209
First received: March 12, 2008
Last updated: March 18, 2008
Last verified: March 2008
History of Changes
  Purpose

The purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver.


Condition Intervention
Human Physiology of Energy Homeostasis
 Drug: Human insulin
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Typ 2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Insulin effect on cortical function (spectral analysis) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I Drug: Human insulin
Placebo Comparator: P Drug: Saline

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-70 Risk factor(s) for type 2 diabetes (e.g. overweight, family history of diabetes)

Exclusion Criteria:

  • Type 2 diabetes pregnancy acute or chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638209

Contacts
Contact: Andreas Fritsche, MD +49 7071 29 80590 andreas.fritsche@med.uni-tuebingen.de

Locations
Germany
University Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Andreas Fritsche     +49 7071 29 80590     andreas.fritsche@med.uni-tuebingen.de    
University Hospital Tuebingen, Internal Medicine IV Recruiting
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
  More Information

No publications provided

Responsible Party: Prof. Andreas Fritsche, University Hospital Tuebingen, Internal Medicine IV
ClinicalTrials.gov Identifier: NCT00638209     History of Changes
Other Study ID Numbers: MEG-KFO-2, EudraCT 2006-004734-32, KFO-114
Study First Received: March 12, 2008
Last Updated: March 18, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013