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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Insulin, Glucose, Healthy Volunteers, Women, Pregnancy

Intervention / Treatment
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* Drug: Kisspeptin-10
* Other: mixed meal tolerance test


Participation Criteria
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Eligibility Criteria
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HISTORY no personal history of chronic disease, except well controlled thyroid disease no history of diabetes in a first degree relative, including gestational diabetes no family or personal history of hyperlipidemia normal timing of menarche (age 10-14) normal menstrual cycles (q25-35 days) no use of contraceptive pills, patches or vaginal rings within last 4 weeks nulliparous (no history of a pregnancy) no active illicit drug use no history of a medication reaction requiring emergency medical care no difficulty with blood draws stable weight for previous three months available for all parts of the study PHYSICAL body mass index (18.5-25) systolic BP < 120mm Hg, diastolic < 80 mm Hg normal waist circumference (less than 32 inches) LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges) fasting LDL cholesterol less than 130 mg/dL fasting triglycerides less than 150 mg/dL normal hemoglobin hemoglobin A1C < 5.7% blood urea nitrogen, creatinine not elevated AST, ALT not elevated negative serum pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: physiologic studies
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kisspeptin-10<br>kisspeptin infusion | Drug: Kisspeptin-10<br>* kisspeptin-10 IV infusion<br>* Other names: kisspeptin;Other: mixed meal tolerance test<br>* mixed meal tolerance test<br>|
| Placebo Comparator: placebo<br>placebo | Other: mixed meal tolerance test<br>* mixed meal tolerance test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-cell responsivity index | Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kisspeptin, follicular phase