Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)
1 other identifier
interventional
12
1 country
1
Brief Summary
Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJune 4, 2019
June 1, 2019
9 months
January 3, 2017
June 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
180 minutes
Study Arms (4)
Placebo
PLACEBO COMPARATORSaline
GIP-A
OTHERInfusion of GIP-A alone as study tool.
GLP-1 receptor antagonist Exendin[9-39]
OTHERInfusion of GLP-1 receptor antagonist Exendin\[9-39\] alone as study tool.
GIP-A + Exendin[9-39]
OTHERInfusion of GIP-A + GLP-1 receptor antagonist Exendin\[9-39\] together as study tools.
Interventions
Exendin\[9-39\]
Eligibility Criteria
You may qualify if:
- Normal kidney function, liver function and hemoglobin levels.
You may not qualify if:
- Medication, Diabetes type 1 or 2, BMI \> 27, first degree relatives with Type 2 Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Diabetes Research
Copenhagen, Gentofte, 2900, Denmark
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.
PMID: 32730920DERIVEDGasbjerg 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.
PMID: 32077470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fip K Knop, MD, PhD
UHGentofte, Center for Diabetes Research
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
January 3, 2017
First Posted
January 6, 2017
Study Start
October 1, 2016
Primary Completion
July 1, 2017
Study Completion
September 1, 2018
Last Updated
June 4, 2019
Record last verified: 2019-06