Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glucose
- Healthy Volunteers
- Insulin
- Pregnancy
- Women
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: physiologic studiesMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
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...
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
Tracking Information
- NCT #
- NCT04532801
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Margaret Lippincott, MD Massachusetts General Hospital
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