Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)
| Registry | NCT03133741, acronym GA-3 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: triple, basic science |
| Enrollment | 18 (Actual) |
| Sponsor | University Hospital, Gentofte, Copenhagen (Other); collaborators: University of Copenhagen |
| Conditions | Glucose Metabolism Disorders |
| Interventions | GIP-A, GLP-1 receptor antagonist Exendin[9-39], Placebo, GIP-A + Exendin[9-39] (Other) |
| Dates | start 2017-03-01, primary completion 2017-07-01, completion 2017-07-01, first posted 2017-04-28, last updated 2017-11-01 |
| Locations | 1 site in Denmark |
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All trials for Glucose Metabolism Disorders All trials of GIP-A All trials of GLP-1 receptor antagonist Exendin[9-39]
Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.
Eighteen healthy men (age 18-70 years, BMI 19-35 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).
| 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. |
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, first degree relatives with Diabetes type 2
| Facility | City | Country | Status |
|---|---|---|---|
| Center for Diabetes Research | Gentofte Municipality, Copenhagen | Denmark |