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OpenTrials
Completed

NCT Number: NCT04958109

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

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

Completed

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History:

  • over the age of 18,
  • normal pubertal development
  • stable weight for previous three months,
  • normal body mass index (BMI between 18.5-25)
  • regular menstrual cycles

Physical examination:

  • systolic BP < 140 mm Hg, diastolic < 90 mm Hg

Laboratory studies: (per Massachusetts General Hospital reference ranges)

  • normal hemoglobin
  • hemoglobin A1C < 6.5%
  • blood urea nitrogen, creatinine not elevated
  • aspartate aminotransferase, alanine aminotransferase < 3x upper limit of normal

Exclusion criteria

  • active illicit drug use,
  • history of a medication reaction requiring emergency medical care,
  • difficulty with blood draws.
  • history of chronic disease, except well controlled thyroid disease,
  • recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
  • history of diabetes in a first degree relative,
  • use of contraceptive pills, patches or vaginal rings within last 4 weeks.
  • hyperlipidemia by fasting lipid panel
  • positive serum pregnancy test (for all women)

Treatment and study plan

Oral glucose tolerance test

Diagnostic Test

Administration of a 75 gm oral glucose tolerance test

Kisspeptin

Drug

Intravenous administration of kisspeptin 112-121 x 16 hours

Placebo

Drug

Intravenous administration of Placebo 16 hours

Primary outcomes

  1. Oral Glucose Sensitivity Index (Kisspeptin-Placebo)

    Time frame: 3 hours

    Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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