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

Last updated: November 19, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

1

Condition

Metabolic Disorders

Treatment

Placebo

Oral Glucose Tolerance Test

Kisspeptin

Clinical Study ID

NCT04958109
267339
5K23HD097296
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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 orreproduction (recent = within 5 half-lives of the drug). Use of levothyroxine orseasonal 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)

Study Design

Total Participants: 16
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 28, 2021
Estimated Completion Date:
October 31, 2022

Study Description

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

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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