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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04532801
Study type Interventional
Source Massachusetts General Hospital
Contact Margaret Lippincott, MD
Phone 617-726-8434
Email mlippincott@mgh.harvard.edu
Status Recruiting
Phase Phase 1
Start date September 1, 2019
Completion date December 21, 2024

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