Metabolic Disease
Conditions
Brief summary
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp
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
Interventions
DIAGNOSTIC_TESTHyperglycemic Clamp
Administration of a hyperglycemic clamp
DRUGKisspeptin-10
Administration of kisspeptin-10 \* 16 hr
DRUGPlacebo
Administration of placebo \*16 hr
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Phase Insulin Secretion | 10 minutes | Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms |
| Second Phase Insulin Secretion | 2 hours | Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms |
Countries
United States
Outcome results
None listed