Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue

This study has been completed.

Sponsor:

Collaborator:

German Research Foundation

Information provided by:

German Institute of Human Nutrition

ClinicalTrials.gov Identifier:

NCT00774488

First received: October 16, 2008

Last updated: NA

Last verified: October 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 16, 2008
Last Updated Date	October 16, 2008
Start Date ^ICMJE	January 2006
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2008)	Changes in gene expression of subcutaneous adipose tissue with microarray analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: October 16, 2008)	Analysis of inflammatory marker (blood levels and gene expression), Activity of 11beta HSD and 11-beta HSD mRNA in adipose tissue, etc. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
Official Title ^ICMJE	Not Provided
Brief Summary	This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Condition ^ICMJE	Metabolic Syndrome Obesity Insulin Sensitivity
Intervention ^ICMJE	Other: Glucose dependent insulinotropic polypeptide (GIP) GIP-Infusions for 4 h in a postprandial concentration
Study Arm (s)	Not Provided
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	Completed
Enrollment ^ICMJE	17
Completion Date	July 2007
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: BMI > 28 Healthy subjects Normal glucose tolerance Exclusion Criteria: Diabetes,IFG, IGT Chronical-inflammatory diseases Hb < 12g/dl Elevation in liver enzymes or creatinin concentrations Great weight changes within last 12 months Any cancer diagnosis in last 10 years
Gender	Male
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00774488
Other Study ID Numbers ^ICMJE	GIP-Genexpression Study
Has Data Monitoring Committee	Yes
Responsible Party	AFH. Pfeiffer, German Institute of Human Nutrition
Study Sponsor ^ICMJE	German Institute of Human Nutrition
Collaborators ^ICMJE	German Research Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	German Institute of Human Nutrition
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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