Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

What Was Tested

In this phase 1 trial, researchers set out to test Kisspeptin-10.

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp.

It had two arms (groups): Kisspeptin (experimental) and Placebo (placebo comparator).

Intravenous administration of kisspeptin 112-121 x 16 hours.

Intravenous administration of placebo x 16 hours.

The registry classes the interventions as diagnostic test and drug.

More on the Plan

Assignment: Each study subject will serve as their own control.

The order of the visits will be randomized.

Delivery of Interventions: Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.

During the inpatient study, the subjects will Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp.

Who Took Part

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Over the age of 17. Normal pubertal development. Regular menstrual cycles. Stable weight for previous three months. Normal body mass index.

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: active illicit drug use,; history of a medication reaction requiring emergency medical care,; difficulty with blood draws.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this Kisspeptin-10 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Kisspeptin-10 and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Kisspeptin-10, so expectations could not easily colour the readings.

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

It started in 2022-06-03 with completion listed for 2024-08-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: First Phase Insulin Secretion (time frame: 10 minutes). Second Phase Insulin Secretion (time frame: 2 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Kisspeptin-10 in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Kisspeptin-10 compound page, all human trials.