Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Last updated: August 11, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Trial Not Available

Phase

1

Condition

Metabolic Disorders

Treatment

Placebo

Kisspeptin-10

Hyperglycemic Clamp

Clinical Study ID

NCT05456854
267335
  • 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 hyperglycemic clamp

Eligibility Criteria

Inclusion

  • over the age of 17

  • normal pubertal development

  • regular menstrual cycles

  • stable weight for previous three months

  • normal body mass index

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

  • normal hemoglobin

  • hemoglobin A1C < 6.5%

  • BUN, creatinine not elevated

  • AST, ALT < 3x upper limit of normal

  • negative serum pregnancy test

Exclusion

Exclusion Criteria:

  • active illicit drug use,

  • history of a medication reaction requiring emergency medical care,

  • difficulty with blood draws.

  • history of hypertension, diabetes, heart disease, high cholesterol, cancer, orclotting disorders.

  • history of chronic disease that has required hospitalization

  • recent use of prescription medications which interfere with metabolism orreproduction (recent = within 5 half-lives of the drug) unless it is birth control

  • history of diabetes in a first degree relative

  • hyperlipidemia by fasting lipid panel

Study Design

Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 03, 2022
Estimated Completion Date:
August 01, 2024

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 a hyperglycemic clamp

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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