Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Purpose
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp
Condition
- Metabolic Disease
Eligibility
- Eligible Ages
- Between 18 Years and 40 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Criteria
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Kisspeptin |
Intravenous administration of kisspeptin 112-121 x 16 hours |
|
|
Placebo Comparator Placebo |
Intravenous administration of placebo x 16 hours |
|
Recruiting Locations
Boston, Massachusetts 02114
Margaret Lippincott
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
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