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

Recruiting
18 - 40 years of age
Female
Phase 1

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Overview

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

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

Eligibility

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 MGH reference ranges)

  • normal hemoglobin
  • hemoglobin A1C < 6.5%
  • BUN, creatinine not elevated
  • AST, ALT < 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)

Study details

Metabolic Diseases

NCT04958109

Massachusetts General Hospital

26 January 2024

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