Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

What Was Tested

This registered phase 1 trial tested Kisspeptin-10.

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test.

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 an oral glucose tolerance test.

Who Took Part

Enrollment: 16 actual participants 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 18,. Stable weight for previous three months,. Normal body mass index (BMI between 18.5-25). Regular menstrual cycles. Blood urea nitrogen, creatinine not elevated.

The full record lists 9 inclusion and 9 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.

The participants were allocated by chance, so the Kisspeptin-10 group and the comparison group should start out alike.

Each person switched between Kisspeptin-10 and the comparison at some point, usually with a gap in between.

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 2021-10-28 with completion listed for 2022-10-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Oral Glucose Sensitivity Index (Kisspeptin-Placebo) (time frame: 3 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Kisspeptin-10 in 16 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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