Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
- Conditions
- GlucoseHealthy VolunteersPregnancyInsulinWomen
- Interventions
- Other: mixed meal tolerance test
- Registration Number
- NCT04532801
- Lead Sponsor
- Stephanie B. Seminara, MD
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description kisspeptin-10 mixed meal tolerance test kisspeptin infusion placebo mixed meal tolerance test placebo kisspeptin-10 Kisspeptin-10 kisspeptin infusion
- Primary Outcome Measures
Name Time Method Beta-cell responsivity index up to 6 months Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States