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KP-10 and Insulin Secretion in Men
Plain-language guide to NCT03771326: phase 3 randomized trial of Kisspeptin-10, 14 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03771326
- Phase
- phase 3
- Status
- completed
- Start
- 2013-10-29
- Completion (planned or actual)
- 2013-11-04
- Participants
- 14 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Kisspeptin Action on Insulin in Healthy Normal Men; Kisspeptin Action on Insulin in Obese Diabetic Men
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Kisspeptin-10.
Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear.
The present study was designed to investigate the role of KP-10 on insulin secretion in adult healthy and obese men with insulin resistance.
The aim of selection of obese persons for the present study was to investigate the effect of acute KP-10 administration in a metabolically challenged condition where the pancreatic beta cells are already highly activated.
It had two arms (groups): obese men (experimental) and Normal men (experimental).
The registry classes the interventions as biological.
Who Took Part
The registry lists 14 actual participants took part.
It was open to men only aged from 20 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Normal renal function. Normal liver function. Normal blood count.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: disease history; other trauma.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Kisspeptin-10 study: the participants and staff both knew the treatment.
It started in 2013-10-29 with completion listed for 2013-11-04.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Changes in the response of insulin secretion to acute exogenous kisspeptin administration.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Kisspeptin-10 in 14 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 Kisspeptin-10 compound page, all human trials.
Our Notes on the Compound
Kisspeptin-10: A hypothalamic signaling peptide that triggers GnRH, and through it LH and FSH.
Related Pages
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.