NCT03133741

Brief Summary

Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

April 25, 2017

Last Update Submit

October 30, 2017

Conditions

Keywords

GIPGIP receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • Insulin levels

    Serum insulin AUC (area under the curve)

    240 minutes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Saline

Other: Placebo

GIP-A

OTHER

Infusion of GIP-A alone as study tool.

Other: GIP-A

GLP-1 receptor antagonist Exendin[9-39]

OTHER

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

Other: GLP-1 receptor antagonist Exendin[9-39]

GIP-A + Exendin[9-39]

OTHER

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

Other: GIP-A + Exendin[9-39]

Interventions

GIP-AOTHER

GIP-A (GIP receptor antagonist)

GIP-A

Exendin\[9-39\]

Also known as: EX(9-39)
GLP-1 receptor antagonist Exendin[9-39]
PlaceboOTHER

Saline (9mg/mL)

Also known as: Saline
Placebo

GIP receptor antagonist + GLP-1 receptor antagonist

GIP-A + Exendin[9-39]

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal kidney function, liver function and hemoglobin levels.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research

Gentofte Municipality, Copenhagen, 2900, Denmark

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Sodium Chlorideexendin (9-39)

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Filip K Knop, MD, PhD

    UHGentofte, Center for Diabetes Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

March 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations