Kisspeptin Influence on Glucose Homeostasis

2016P001769

The goal of this study is to learn about how a naturally occurring hormone called kisspeptin affects blood sugar and insulin levels.

2017-07-18

2024-08-01

2024-08-01

Recruiting

Early phase I

413

Inclusion/Exclusion Criteria: History: * normal pubertal development * stable weight for previous three months * no active illicit drug use, * no history of a medication reaction requiring emergency medical care, * no difficulty with blood draws. Physical examination: • systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg, Laboratory studies: (per MGH reference ranges) * normal hemoglobin, unless hypogonadal then no lower than 0.5 gm/dL below the lower limit of the reference range for normal women (as men and women with hypogonadism have lower hemoglobin levels off of treatment) * hemoglobin A1C \< 6.5% * BUN, creatinine not elevated * AST, ALT \< 3x upper limit of normal * negative serum pregnancy test (for all women) * no hyperlipidemia by fasting lipid panel Additional Criteria by Study Population Healthy Men: * normal body mass index (BMI between 18.5-25) * no history of chronic disease, except well controlled thyroid disease * no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable. * no history of diabetes in a first degree relative. Healthy Women: * normal body mass index (BMI between 18.5-25) * no history of chronic disease, except well controlled thyroid disease, * no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable. * no history of diabetes in a first degree relative, * no use of contraceptive pills, patches or vaginal rings within last 4 weeks. * regular menstrual cycles Postmenopausal Women: * body mass index (BMI between 18.5-30) * no history of chronic disease except thyroid disease, and osteoporosis, * no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine, osteoporosis medications or seasonal allergy medications is acceptable, * no history of diabetes in a first degree relative, * normal activate protein C resistance screen, * if applicable, able to undergo appropriate washout from hormone therapy. Men and Women with Impaired Glucose Tolerance (IGT): * diagnosis of impaired glucose tolerance by oral glucose tolerance test, * all medical conditions well-controlled. Men and Women with Hypogonadism * diagnosis of hypogonadism, * all other medical conditions well-controlled, * if applicable, able to undergo appropriate washout from hormone therapy.

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2023-07-19