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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
  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)

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

Resource links provided by NLM:


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:
    Other: Glucose dependent insulinotropic polypeptide (GIP)
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: AFH. Pfeiffer, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT00774488     History of Changes
Other Study ID Numbers: GIP-Genexpression Study
Study First Received: October 16, 2008
Last Updated: October 16, 2008
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

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Gastric Inhibitory Polypeptide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014