Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
Primary Purpose
Metabolic Syndrome, Obesity, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glucose dependent insulinotropic polypeptide (GIP)
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome focused on measuring Euglycemic-hyperinsulinemic clamp, fat biopsies, microarray analysis, quantitative real time PCR, overnutrition, low grade-inflammation
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Changes in gene expression of subcutaneous adipose tissue with microarray analysis
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.
Full Information
NCT ID
NCT00774488
First Posted
October 16, 2008
Last Updated
October 16, 2008
Sponsor
German Institute of Human Nutrition
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00774488
Brief Title
Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Insulin Sensitivity
Keywords
Euglycemic-hyperinsulinemic clamp, fat biopsies, microarray analysis, quantitative real time PCR, overnutrition, low grade-inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Glucose dependent insulinotropic polypeptide (GIP)
Intervention Description
GIP-Infusions for 4 h in a postprandial concentration
Primary Outcome Measure Information:
Title
Changes in gene expression of subcutaneous adipose tissue with microarray analysis
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
34226282
Citation
Tuvia N, Pivovarova-Ramich O, Murahovschi V, Luck S, Grudziecki A, Ost AC, Kruse M, Nikiforova VJ, Osterhoff M, Gottmann P, Gogebakan O, Sticht C, Gretz N, Schupp M, Schurmann A, Rudovich N, Pfeiffer AFH, Kramer A. Insulin Directly Regulates the Circadian Clock in Adipose Tissue. Diabetes. 2021 Sep;70(9):1985-1999. doi: 10.2337/db20-0910. Epub 2021 Jul 5.
Results Reference
derived
PubMed Identifier
25994074
Citation
Gogebakan O, Osterhoff MA, Schuler R, Pivovarova O, Kruse M, Seltmann AC, Mosig AS, Rudovich N, Nauck M, Pfeiffer AF. GIP increases adipose tissue expression and blood levels of MCP-1 in humans and links high energy diets to inflammation: a randomised trial. Diabetologia. 2015 Aug;58(8):1759-68. doi: 10.1007/s00125-015-3618-4. Epub 2015 May 21.
Results Reference
derived
PubMed Identifier
25538323
Citation
Rudovich N, Pivovarova O, Gogebakan O, Sparwasser A, Doehner W, Anker SD, Arafat AM, Bergmann A, Nauck MA, Pfeiffer AF. Effect of exogenous intravenous administrations of GLP-1 and/or GIP on circulating pro-atrial natriuretic peptide in subjects with different stages of glucose tolerance. Diabetes Care. 2015 Jan;38(1):e7-8. doi: 10.2337/dc14-1452. No abstract available.
Results Reference
derived
Learn more about this trial
Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
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