search
Back to results

Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)

Primary Purpose

Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP-A
GLP-1 receptor antagonist Exendin[9-39]
Placebo
GIP-A + Exendin[9-39]
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders focused on measuring GIP, GIP receptor antagonist

Eligibility Criteria

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

Inclusion Criteria:

  • Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

  • Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2

Sites / Locations

  • Center for Diabetes Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Other

Other

Other

Arm Label

Placebo

GIP-A

GLP-1 receptor antagonist Exendin[9-39]

GIP-A + Exendin[9-39]

Arm Description

Saline

Infusion of GIP-A alone as study tool.

Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool.

Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools.

Outcomes

Primary Outcome Measures

Insulin levels
Serum insulin AUC (area under the curve)

Secondary Outcome Measures

Full Information

First Posted
April 25, 2017
Last Updated
October 30, 2017
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT03133741
Brief Title
Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist
Acronym
GA-3
Official Title
Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.
Detailed Description
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR. Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders
Keywords
GIP, GIP receptor antagonist

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Arm Title
GIP-A
Arm Type
Other
Arm Description
Infusion of GIP-A alone as study tool.
Arm Title
GLP-1 receptor antagonist Exendin[9-39]
Arm Type
Other
Arm Description
Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool.
Arm Title
GIP-A + Exendin[9-39]
Arm Type
Other
Arm Description
Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools.
Intervention Type
Other
Intervention Name(s)
GIP-A
Intervention Description
GIP-A (GIP receptor antagonist)
Intervention Type
Other
Intervention Name(s)
GLP-1 receptor antagonist Exendin[9-39]
Other Intervention Name(s)
EX(9-39)
Intervention Description
Exendin[9-39]
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Saline (9mg/mL)
Intervention Type
Other
Intervention Name(s)
GIP-A + Exendin[9-39]
Intervention Description
GIP receptor antagonist + GLP-1 receptor antagonist
Primary Outcome Measure Information:
Title
Insulin levels
Description
Serum insulin AUC (area under the curve)
Time Frame
240 minutes

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: Normal kidney function, liver function and hemoglobin levels. Exclusion Criteria: Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip K Knop, MD, PhD
Organizational Affiliation
UHGentofte, Center for Diabetes Research
Official's Role
Study Director
Facility Information:
Facility Name
Center for Diabetes Research
City
Gentofte
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32730920
Citation
Helsted MM, Gasbjerg LS, Lanng AR, Bergmann NC, Stensen S, Hartmann B, Christensen MB, Holst JJ, Vilsboll T, Rosenkilde MM, Knop FK. The role of endogenous GIP and GLP-1 in postprandial bone homeostasis. Bone. 2020 Nov;140:115553. doi: 10.1016/j.bone.2020.115553. Epub 2020 Jul 27.
Results Reference
derived
PubMed Identifier
30626611
Citation
Gasbjerg LS, Helsted MM, Hartmann B, Jensen MH, Gabe MBN, Sparre-Ulrich AH, Veedfald S, Stensen S, Lanng AR, Bergmann NC, Christensen MB, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. Separate and Combined Glucometabolic Effects of Endogenous Glucose-Dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1 in Healthy Individuals. Diabetes. 2019 May;68(5):906-917. doi: 10.2337/db18-1123. Epub 2019 Jan 9.
Results Reference
derived

Learn more about this trial

Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist

We'll reach out to this number within 24 hrs