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

NCT03013296 — Not applicable, Completed, 12 participants, University Hospital, Gentofte, Copenhagen

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Registry	NCT03013296
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, basic science
Enrollment	12 (Actual)
Sponsor	University Hospital, Gentofte, Copenhagen (Other); collaborators: University of Copenhagen
Conditions	Glucose Metabolism Disorders
Interventions	GIP-A, Placebo, GLP-1 receptor antagonist Exendin[9-39], GIP-A + Exendin[9-39] (Other)
Dates	start 2016-10-01, primary completion 2017-07-01, completion 2018-09-01, first posted 2017-01-06, last updated 2019-06-04
Locations	1 site in Denmark

-Summary

Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Other: Placebo	Saline
GIP-A	Other	Other: GIP-A	Infusion of GIP-A alone as study tool.
GLP-1 receptor antagonist Exendin[9-39]	Other	Other: GLP-1 receptor antagonist Exendin[9-39]	Infusion of GLP-1 receptor antagonist Exendin\[9-39\] alone as study tool.
GIP-A + Exendin[9-39]	Other	Other: GIP-A + Exendin[9-39]	Infusion of GIP-A + GLP-1 receptor antagonist Exendin\[9-39\] together as study tools.

GIP-A (Other): GIP-A
Placebo (Other): Placebo
GLP-1 receptor antagonist Exendin[9-39] (Other), also known as Ex(9-39): Exendin\[9-39\]
GIP-A + Exendin[9-39] (Other): GIP-A + Exendin\[9-39\]

+Outcome measures

Primary outcomes

C-peptide levels [180 minutes]: Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).

+Eligibility

Sex: Male, ages: 18 Years to 70 Years, accepts 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

+Locations (1)

Facility	City	Country	Status
Center for Diabetes Research	Copenhagen, Gentofte	Denmark

+Publications

Results publication: 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 32730920
Results publication: 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. PMID 32077470

+Investigators

Fip K Knop, MD, PhD, Study director, UHGentofte, Center for Diabetes Research

My Notes

Public

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