Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    25
  • sponsor
    Stephanie B. Seminara, MD
Updated on 13 July 2022
diabetes
body mass index
chronic disease
illicit drugs
Accepts healthy volunteers

Summary

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

Description

Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.

Delivery of Interventions:

Prior to each visit, study subjects will be asked to:

  • eat at least 150 gm carbohydrates per day
  • refrain from strenuous exercise

On the day of the visit, study subjects will:

  • eat a standardized meal prepared by the metabolic kitchen in the clinical research center
  • be observed overnight to ensure a 12-hour fast
  • have an IV placed, for a 16 hour kisspeptin or placebo infusion
  • after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test

Details
Condition Insulin, Glucose, Healthy Volunteers, Women, Pregnancy
Treatment Mixed meal tolerance test, Kisspeptin-10
Clinical Study IdentifierNCT04532801
SponsorStephanie B. Seminara, MD
Last Modified on13 July 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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