Kisspeptin Influence on Glucose Homeostasis

Stephanie B. Seminara, MD

Status and phase: Completed; Phase 1

Conditions: Impaired Glucose Tolerance; Hypogonadism

Treatments: Other: Insulin Resistance Test; Other: Placebo; Drug: kisspeptin 112-121

Study type: Interventional

Funder types: Other

Identifiers

NCT02953834

2016P001769

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

Kisspeptin and Insulin Resistance Test

Experimental group

Description:

Intravenous (IV) administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose

Treatment:

Drug: kisspeptin 112-121

Other: Insulin Resistance Test

Placebo and Insulin Resistance Test

Placebo Comparator group

Description:

IV administration of fluids that contain no study drug; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose

Treatment:

Other: Placebo

Other: Insulin Resistance Test