The Effect of GIP(3-30)NH2

Overview

Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 1, 2019

Detailed Description

Infusion of glucose-dependent insulintropic polypeptide (GIP) receptor antagonist and evaluation of effect of insulin secretion in healthy subjects. Six study hyperglycemic clamps (10 mmol/l) pr. participant.

Interventions

  • Other: GIP receptor antagonist
    • GIP receptor antagonist
  • Other: GIP receptor agonist
    • GIP(1-42)
  • Other: Saline
    • Placebo (vehicle for infusions)

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo+placebo
    • Saline infusions
  • Active Comparator: GIP+placebo
    • GIP(1-42), receptor agonist
  • Experimental: GIP+dose 1
    • GIP(1-42) and lowest dose of GIP(3-30)NH2
  • Experimental: GIP+dose 2
    • GIP(1-42) and dose of GIP(3-30)NH2
  • Experimental: GIP+dose 3
    • GIP(1-42) and dose of GIP(3-30)NH2
  • Experimental: GIP+dose4
    • GIP(1-42) and highest dose of GIP(3-30)NH2

Clinical Trial Outcome Measures

Primary Measures

  • Insulin secretion
    • Time Frame: 8 weeks
    • Insulin secretion rates (ISR) calculated from serum levels of C-peptide

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy – BMI 19-28 kg/m*m – Stable body weight Exclusion Criteria:

  • Diabetes – Anemia – First-degree relatives with diabetes

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Gentofte, Copenhagen
  • Collaborator
    • Steno Diabetes Center Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lærke Smidt Gasbjerg, MD – University Hospital, Gentofte, Copenhagen

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