Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Phase 1
Withdrawn
- Conditions
- Metabolic Disease
- Interventions
- Registration Number
- NCT05456854
- Lead Sponsor
- Massachusetts General Hospital
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Kisspeptin Kisspeptin-10 Intravenous administration of kisspeptin 112-121 x 16 hours Placebo Hyperglycemic Clamp Intravenous administration of placebo x 16 hours Placebo Placebo Intravenous administration of placebo x 16 hours Kisspeptin Hyperglycemic Clamp Intravenous administration of kisspeptin 112-121 x 16 hours
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States