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

This study has been completed.

Sponsors and Collaborators:	German Institute of Human Nutrition German Research Foundation
Information provided by:	German Institute of Human Nutrition
ClinicalTrials.gov Identifier:	NCT00774488

Purpose

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.

Condition	Intervention
Metabolic Syndrome Obesity Insulin Sensitivity	Other: Glucose dependent insulinotropic polypeptide (GIP)

MedlinePlus related topics: Obesity

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study

Further study details as provided by German Institute of Human Nutrition:

Primary Outcome Measures:

Changes in gene expression of subcutaneous adipose tissue with microarray analysis [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	17
Study Start Date:	January 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Intervention Details:

GIP-Infusions for 4 h in a postprandial concentration

Eligibility

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	German Institute of Human Nutrition ( AFH. Pfeiffer )
Study ID Numbers:	GIP-Genexpression Study
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00774488
Health Authority:	Germany: Ethics Commission

Keywords provided by German Institute of Human Nutrition:

Euglycemic-hyperinsulinemic clamp
fat biopsies
microarray analysis

quantitative real time PCR
overnutrition
low grade-inflammation

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Gastric Inhibitory Polypeptide

Nutrition Disorders
Overweight
Overnutrition
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs

Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009