Back to resultsInsulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2
Primary Purpose
Human Physiology of Energy Homeostasis
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Human insulin
Saline
Sponsored by
About this trial
This is an interventional basic science trial for Human Physiology of Energy Homeostasis
Eligibility 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
Sites / Locations
- University Hospital Tuebingen, Internal Medicine IVRecruiting
- University Hospital TuebingenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
I
P
Arm Description
Outcomes
Primary Outcome Measures
Insulin effect on cortical function (spectral analysis)
Secondary Outcome Measures
Full Information
NCT ID
NCT00638209
First Posted
March 12, 2008
Last Updated
March 18, 2008
Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00638209
Brief Title
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2
Official Title
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Typ 2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate whether insulin sensitivity of the human brain correlates with insulin sensitivity of the liver.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Physiology of Energy Homeostasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Human insulin
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Insulin effect on cortical function (spectral analysis)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Fritsche, MD
Phone
+49 7071 29 80590
Email
andreas.fritsche@med.uni-tuebingen.de
Facility Information:
Facility Name
University Hospital Tuebingen, Internal Medicine IV
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Fritsche
Phone
+49 7071 29 80590
Email
andreas.fritsche@med.uni-tuebingen.de
12. IPD Sharing Statement
Learn more about this trial
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2
We'll reach out to this number within 24 hrs