Kisspeptin Influence on Glucose Homeostasis

Hypogonadism Clinical Trial

Official title:

Kisspeptin Influence on Glucose Homeostasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02953834
• Other study ID #: 2016P001769
• Status: Recruiting
• Phase: Phase 1
• Start date: July 18, 2017
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: Margaret Lippincott, MD
• Phone: 617-726-8434
• Email: mlippincott[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 413
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypogonadism
• Impaired Glucose Tolerance

Intervention

Drug:
• kisspeptin 112-121
Dose: 0.313-12.5 mcg/kg Duration: up to 16 hours

Other:
• Insulin Resistance Test
Eat or drink a standard meal OR drink a standard drink containing 75 grams of sugar
• Placebo
Receive IV fluids for up to 16 hours that do not contain any study drug

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie B. Seminara, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average difference in area under the curve of insulin in response to a mixed meal tolerance test	Compares difference on and off kisspeptin	4 hours
Secondary	Average difference in area under the curve of glucose in response to a mixed meal tolerance test	Compares difference on and off kisspeptin	4 hours
Secondary	Average difference in area under the curve of glucagon-like peptide 1 in response to a mixed meal tolerance test	Compares difference on and off kisspeptin	4 hours