Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

What Was Tested

This registered phase 1 trial tested Kisspeptin-10.

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

It had two arms (groups): kisspeptin-10 (experimental) and placebo (placebo comparator).

Kisspeptin infusion.

Placebo.

The registry classes the interventions as drug and other.

More on the Plan

Assignment: each study subject serves as their own control, and will come in timed to their cycle.

The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.

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: No personal history of chronic disease, except well controlled thyroid disease. No history of diabetes in a first degree relative, including gestational diabetes. No family or personal history of hyperlipidemia. Normal timing of menarche (age 10-14). Normal menstrual cycles (q25-35 days).

The full record lists 22 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Kisspeptin-10 and who got the comparison, which limits bias.

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

As a double-blind Kisspeptin-10 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 2019-09-01 with completion listed for 2024-08-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Beta-cell responsivity index (time frame: up to 6 months).

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It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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