Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Study Overview
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Brief Summary
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The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

Detailed Description
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Assignment: Each study subject will serve as their own control. The order of the visits will be randomized. Delivery of Interventions: Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. During the inpatient study, the subjects will Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp

Official Title
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Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Conditions
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Metabolic Disease

Intervention / Treatment
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* Diagnostic Test: Hyperglycemic Clamp
* Drug: Kisspeptin-10
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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over the age of 17 normal pubertal development regular menstrual cycles stable weight for previous three months normal body mass index blood pressure systolic BP < 140 mm Hg, diastolic < 90 mm Hg normal hemoglobin hemoglobin A1C < 6.5% BUN, creatinine not elevated AST, ALT < 3x upper limit of normal negative serum pregnancy test Exclusion Criteria: active illicit drug use, history of a medication reaction requiring emergency medical care, difficulty with blood draws. history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders. history of chronic disease that has required hospitalization recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control history of diabetes in a first degree relative hyperlipidemia by fasting lipid panel

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kisspeptin<br>Intravenous administration of kisspeptin 112-121 x 16 hours | Diagnostic Test: Hyperglycemic Clamp<br>* Administration of a hyperglycemic clamp<br>Drug: Kisspeptin-10<br>* Administration of kisspeptin-10 * 16 hr<br>|
| Placebo Comparator: Placebo<br>Intravenous administration of placebo x 16 hours | Diagnostic Test: Hyperglycemic Clamp<br>* Administration of a hyperglycemic clamp<br>Drug: Placebo<br>* Administration of placebo *16 hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Phase Insulin Secretion | Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms | 10 minutes | 
| Second Phase Insulin Secretion | Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms | 2 hours |