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

Human Physiology of Energy Homeostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00638209
• Other study ID #: MEG-KFO-2
• Secondary ID: EudraCT 2006-004
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2008
• Last updated: March 18, 2008
• Start date: February 2008

Study information

• Verified date: March 2008
• Source: University Hospital Tuebingen
• Contact: Andreas Fritsche, MD
• Phone: +49 7071 29 80590
• Email: andreas.fritsche[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Human Physiology of Energy Homeostasis

Intervention

Drug:
• Human insulin

• Saline

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen
Germany	University Hospital Tuebingen, Internal Medicine IV	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin effect on cortical function (spectral analysis)		2 weeks	No