GA-10: The Effect of GIP(3-30)NH2

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT03770910

Collaborator

Steno Diabetes Center Copenhagen (Other), University of Copenhagen (Other)

Enrollment

Locations

Arms

11.8

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endocrine - Other	Other: GIP receptor antagonist Other: GIP receptor agonist Other: Saline	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

The Effect of GIP(3-30)NH2

Actual Study Start Date :

Dec 6, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo+placebo Saline infusions	Other: Saline Placebo (vehicle for infusions)
Active Comparator: GIP+placebo GIP(1-42), receptor agonist	Other: GIP receptor agonist GIP(1-42) Other: Saline Placebo (vehicle for infusions)
Experimental: GIP+dose 1 GIP(1-42) and lowest dose of GIP(3-30)NH2	Other: GIP receptor antagonist GIP receptor antagonist Other: GIP receptor agonist GIP(1-42)
Experimental: GIP+dose 2 GIP(1-42) and dose of GIP(3-30)NH2	Other: GIP receptor antagonist GIP receptor antagonist Other: GIP receptor agonist GIP(1-42)
Experimental: GIP+dose 3 GIP(1-42) and dose of GIP(3-30)NH2	Other: GIP receptor antagonist GIP receptor antagonist Other: GIP receptor agonist GIP(1-42)
Experimental: GIP+dose4 GIP(1-42) and highest dose of GIP(3-30)NH2	Other: GIP receptor antagonist GIP receptor antagonist Other: GIP receptor agonist GIP(1-42)

Outcome Measures

Primary Outcome Measures

Insulin secretion [8 weeks]
Insulin secretion rates (ISR) calculated from serum levels of C-peptide

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy
BMI 19-28 kg/m*m
Stable body weight

Exclusion Criteria:

Diabetes
Anemia
First-degree relatives with diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Metabolic Physiology	Gentofte	Copenhagen	Denmark	2900
2	Clinical Metabolic Physiology	Copenhagen	Gentofte	Denmark	2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen
Steno Diabetes Center Copenhagen
University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lærke Smidt Gasbjerg, MD, University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT03770910

Other Study ID Numbers:

SDCC_CMP_GA-10

First Posted:

Dec 10, 2018

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lærke Smidt Gasbjerg, MD, University Hospital, Gentofte, Copenhagen

GIP

Insulin secretin

Incretin hormone

Study Results

No Results Posted as of Mar 26, 2020