Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
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- STATUS
- Recruiting
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- End date
- Aug 31, 2024
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- participants needed
- 25
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- sponsor
- Stephanie B. Seminara, MD
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 Identifier | NCT04532801 |
| Sponsor | Stephanie B. Seminara, MD |
| Last Modified on | 13 July 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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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