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

Tracking Information

First Received Date ^ICMJE

March 12, 2008

Last Updated Date

March 18, 2008

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638209 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Condition ^ICMJE

Human Physiology of Energy Homeostasis

Intervention ^ICMJE

Drug: Human insulin
Drug: Saline

Study Arm (s)

Active Comparator: I
Intervention: Drug: Human insulin
Placebo Comparator: P
Intervention: Drug: Saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Andreas Fritsche, MD

+49 7071 29 80590

andreas.fritsche@med.uni-tuebingen.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00638209

Other Study ID Numbers ^ICMJE

MEG-KFO-2, EudraCT 2006-004734-32, KFO-114

Has Data Monitoring Committee

Responsible Party

Prof. Andreas Fritsche, University Hospital Tuebingen, Internal Medicine IV

Study Sponsor ^ICMJE

University Hospital Tuebingen

Collaborators ^ICMJE

German Research Foundation

Investigators ^ICMJE

Not Provided

Information Provided By

University Hospital Tuebingen

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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