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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
German Institute of Human Nutrition
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    October 16, 2008
    Last Updated
    October 16, 2008
    Sponsor
    German Institute of Human Nutrition
    Collaborators
    German Research Foundation
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    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

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

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