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

  • STATUS
    Recruiting
  • End date
    Aug 7, 2024
  • participants needed
    16
  • sponsor
    Massachusetts General Hospital
Updated on 7 July 2022
Accepts healthy volunteers

Summary

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

Details
Condition Metabolic Diseases
Treatment Placebo, Oral glucose tolerance test, kisspeptin
Clinical Study IdentifierNCT04958109
SponsorMassachusetts General Hospital
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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