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Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)

Primary Purpose

Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP-A
Placebo
GLP-1 receptor antagonist Exendin[9-39]
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, BMI > 27, first degree relatives with Type 2 Diabetes

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

C-peptide levels
Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).

Secondary Outcome Measures

Full Information

First Posted
January 3, 2017
Last Updated
June 1, 2019
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03013296
Brief Title
Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)
Official Title
Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2018 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.
Detailed Description
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including lipid, bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the GIPR. Twelve healthy men (age 18-70 years, BMI 19-27 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
12 (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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
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)
GIP-A + Exendin[9-39]
Intervention Description
GIP-A + Exendin[9-39]
Primary Outcome Measure Information:
Title
C-peptide levels
Description
Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).
Time Frame
180 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, BMI > 27, first degree relatives with Type 2 Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fip 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
Copenhagen
State/Province
Gentofte
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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
32077470
Citation
Gasbjerg LS, Helsted MM, Hartmann B, Sparre-Ulrich AH, Veedfald S, Stensen S, Lanng AR, Bergmann NC, Christensen MB, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. GIP and GLP-1 Receptor Antagonism During a Meal in Healthy Individuals. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz175. doi: 10.1210/clinem/dgz175.
Results Reference
derived

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Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)

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