Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test GIP (Gastric Inhibitory Polypeptide).

The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose.

It had three arms (groups): Healthy volunteers (experimental), Patients with Type 1 diabetes mellitus (experimental) and Patients with type 2 diabetes mellitus (experimental).

The registry classes the interventions as drug.

More on the Plan

The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.

From this, the researchers will evaluate GIP's role as blood sugar stabilizer.

Who Took Part

The registry lists 30 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR. Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got GIP (Gastric Inhibitory Polypeptide) and who got the comparison, which limits bias.

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

As a double-blind GIP (Gastric Inhibitory Polypeptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-12 with completion listed for 2014-04.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon (time frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit).

It also tracked 1 secondary outcome, for example The difference between the amount of infused glucose and the insulin responses.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of GIP (Gastric Inhibitory Polypeptide) in 30 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.