Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

Healthy Volunteers Clinical Trial

Official title:

Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04532801
• Other study ID #: 267337
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: December 21, 2024

Study information

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

Clinical Trial Summary

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

Description:

Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects. Delivery of Interventions: Prior to each visit, study subjects will be asked to: - eat at least 150 gm carbohydrates per day - refrain from strenuous exercise On the day of the visit, study subjects will: - eat a standardized meal prepared by the metabolic kitchen in the clinical research center - be observed overnight to ensure a 12-hour fast - have an IV placed, for a 16 hour kisspeptin or placebo infusion - after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 21, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

HISTORY

• no personal history of chronic disease, except well controlled thyroid disease
• no history of diabetes in a first degree relative, including gestational diabetes
• no family or personal history of hyperlipidemia
• normal timing of menarche (age 10-14)
• normal menstrual cycles (q25-35 days)
• no use of contraceptive pills, patches or vaginal rings within last 4 weeks
• nulliparous (no history of a pregnancy)
• no active illicit drug use
• no history of a medication reaction requiring emergency medical care
• no difficulty with blood draws
• stable weight for previous three months
• available for all parts of the study PHYSICAL
• body mass index (18.5-25)
• systolic BP < 120mm Hg, diastolic < 80 mm Hg
• normal waist circumference (less than 32 inches) LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)
• fasting LDL cholesterol less than 130 mg/dL
• fasting triglycerides less than 150 mg/dL
• normal hemoglobin
• hemoglobin A1C < 5.7%
• blood urea nitrogen, creatinine not elevated
• AST, ALT not elevated
• negative serum pregnancy test

Related Conditions & MeSH terms

• Glucose
• Healthy Volunteers
• Insulin
• Pregnancy
• Women

Intervention

Drug:
• Kisspeptin-10
kisspeptin-10 IV infusion

Other:
• mixed meal tolerance test
mixed meal tolerance test

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
Other	Fasting insulin level	Average fasting insulin level comparing placebo and kisspeptin arms	up to 6 months
Primary	Beta-cell responsivity index	Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms	up to 6 months