Kisspeptin Influence on Glucose Homeostasis

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines how a naturally occurring peptide called kisspeptin might regulate blood sugar and insulin levels.

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

Details

• Lead Sponsor: Stephanie B. Seminara, MD
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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.