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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00774488
Other study ID # GIP-Genexpression Study
Secondary ID
Status Completed
Phase N/A
First received October 16, 2008
Last updated October 16, 2008
Start date January 2006
Est. completion date July 2007

Study information

Verified date October 2008
Source German Institute of Human Nutrition
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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


Intervention

Other:
Glucose dependent insulinotropic polypeptide (GIP)
GIP-Infusions for 4 h in a postprandial concentration

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
German Institute of Human Nutrition German Research Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in gene expression of subcutaneous adipose tissue with microarray analysis 3 years No
Secondary Analysis of inflammatory marker (blood levels and gene expression), Activity of 11beta HSD and 11-beta HSD mRNA in adipose tissue, etc. 3 years No
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