Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
- Conditions
- Metabolic Diseases
- Interventions
- Registration Number
- NCT04958109
- 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 oral glucose tolerance test
- 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 an oral glucose tolerance test
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
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 Massachusetts General Hospital reference ranges)
- normal hemoglobin
- hemoglobin A1C < 6.5%
- blood urea nitrogen, creatinine not elevated
- aspartate aminotransferase, alanine aminotransferase < 3x upper limit of normal
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Kisspeptin Oral Glucose Tolerance Test • Intravenous administration of kisspeptin 112-121 x 16 hours Placebo Placebo • Intravenous administration of placebo x 16 hours Kisspeptin Kisspeptin • Intravenous administration of kisspeptin 112-121 x 16 hours Placebo Oral Glucose Tolerance Test • Intravenous administration of placebo x 16 hours
- Primary Outcome Measures
Name Time Method Oral Glucose Sensitivity Index (Kisspeptin-Placebo) 3 hours Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States