Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

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 oral glucose tolerance test

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 an oral glucose tolerance test

Official Title
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Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

Conditions
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Metabolic Diseases

Intervention / Treatment
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* Diagnostic Test: Oral Glucose Tolerance Test
* Drug: Kisspeptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History: over the age of 18, normal pubertal development stable weight for previous three months, normal body mass index (BMI between 18.5-25) regular menstrual cycles Physical examination: • systolic BP < 140 mm Hg, diastolic < 90 mm Hg Laboratory studies: (per MGH reference ranges) normal hemoglobin hemoglobin A1C < 6.5% BUN, creatinine not elevated AST, ALT < 3x upper limit of normal Exclusion Criteria: active illicit drug use, history of a medication reaction requiring emergency medical care, difficulty with blood draws. history of chronic disease, except well controlled thyroid disease, recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable, history of diabetes in a first degree relative, use of contraceptive pills, patches or vaginal rings within last 4 weeks. hyperlipidemia by fasting lipid panel positive serum pregnancy test (for all women)

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: Oral Glucose Tolerance Test<br>* Administration of a 75 gm oral glucose tolerance test<br>Drug: Kisspeptin<br>* Intravenous administration of kisspeptin 112-121 x 16 hours<br>|
| Placebo Comparator: Placebo<br>• Intravenous administration of placebo x 16 hours | Diagnostic Test: Oral Glucose Tolerance Test<br>* Administration of a 75 gm oral glucose tolerance test<br>Drug: Placebo<br>* Intravenous administration of Placebo 16 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Difference in Oral glucose Sensitivity Index (Kisspeptin-Placebo) | Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in OGTT | 2 hours |