Incretin Action in Physiology and Diabetes

Plain-language guide to NCT02550548: phase 1 non-randomized trial of GIP (Gastric Inhibitory Polypeptide), 39 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02550548
Phase: phase 1
Status: completed
Start: 2016-04-21
Completion (planned or actual): 2021-04-16
Participants: 39 (actual)
Design: non-randomized, single-blind, basic_science
Conditions studied: Insulin Secretion
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around GIP (Gastric Inhibitory Polypeptide).

This project is designed to advance understanding of the incretin effect in health and disease.

This system of gut-islet linkage is essential for normal glucose tolerance, impaired in T2DM, and amenable to therapeutic intervention.

However, there are important gaps in understanding incretin function that limit application of this system; this project will address several of these.

It had four arms (groups): GIP infusion (experimental), GLP-1 infusion (experimental), GIP + GLP-1 infusion (experimental) and GIP + Ex-9 infusion (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy adult volunteers.

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: rheumatoid arthritis; inflammatory bowel disease; unstable angina or uncompensated heart failure.

How the Study Was Run

Design: non-randomized, parallel-group and single-blind.

The GIP (Gastric Inhibitory Polypeptide) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether GIP (Gastric Inhibitory Polypeptide) was given.

Those kept unaware of assignments: participant.

It started in 2016-04-21 with completion listed for 2021-04-16.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Beta cell sensitivity (time frame: 30 minute infusion periods).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of GIP (Gastric Inhibitory Polypeptide) in 39 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.

Our Notes on the Compound

GIP (Gastric Inhibitory Polypeptide): A 42-amino-acid gut hormone that boosts insulin release after meals; one of the two receptors tirzepatide acts on.

GIP (Gastric Inhibitory Polypeptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.