Kisspeptin Influence on Glucose Homeostasis

Phase 1

Completed

• Conditions: Impaired Glucose Tolerance; Hypogonadism
• Interventions: Other: Insulin Resistance Test; Drug: kisspeptin 112-121; Other: Placebo

• Registration Number: NCT02953834
• Lead Sponsor: Stephanie B. Seminara, MD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2017-07-18
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Insulin Resistance Test	Insulin Resistance Test	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
Placebo and Insulin Resistance Test	Placebo	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
Kisspeptin and Insulin Resistance Test	Insulin Resistance Test	Intravenous (IV) administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
Kisspeptin and Insulin Resistance Test	kisspeptin 112-121	Intravenous (IV) administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose

Primary Outcome Measures

Name	Time	Method
Average difference in area under the curve of insulin in response to a mixed meal tolerance test	4 hours	Compares difference on and off kisspeptin

Secondary Outcome Measures

Name	Time	Method
Average difference in area under the curve of glucose in response to a mixed meal tolerance test	4 hours	Compares difference on and off kisspeptin
Average difference in area under the curve of glucagon-like peptide 1 in response to a mixed meal tolerance test	4 hours	Compares difference on and off kisspeptin

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States