Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stephanie B. Seminara, MD

Criteria

HISTORY

• no personal history of chronic disease, except well controlled thyroid disease

• no history of diabetes in a first degree relative, including gestational diabetes

• no family or personal history of hyperlipidemia

• normal timing of menarche (age 10-14)

• normal menstrual cycles (q25-35 days)

• no use of contraceptive pills, patches or vaginal rings within last 4 weeks

• nulliparous (no history of a pregnancy)

• no active illicit drug use

• no history of a medication reaction requiring emergency medical care

• no difficulty with blood draws

• stable weight for previous three months

• available for all parts of the study

PHYSICAL

• body mass index (18.5-25)

• systolic BP < 120mm Hg, diastolic < 80 mm Hg

• normal waist circumference (less than 32 inches)

LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)

• fasting LDL cholesterol less than 130 mg/dL

• fasting triglycerides less than 150 mg/dL

• normal hemoglobin

• hemoglobin A1C < 5.7%

• blood urea nitrogen, creatinine not elevated

• AST, ALT not elevated

• negative serum pregnancy test