Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

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

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

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 MGH reference ranges)

• normal hemoglobin

• hemoglobin A1C < 6.5%

• BUN, creatinine not elevated

• AST, ALT < 3x upper limit of normal

Exclusion Criteria:

• 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)