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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Healthy Volunteers; Insulin; Glucose; Women
• Intervention / Treatment: Drug: Kisspeptin-10; Other: mixed meal tolerance test

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Margaret Lippincott, MD; Phone Number: 617-726-8434; Email: mlippincott@mgh.harvard.edu
• Study Contact Backup: Name: General Research Email; Email: mghkisspeptinresearch@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Margaret Lippincott, MD; Phone Number: 617-726-8434; Email: mlippincott@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: mixed meal tolerance test; mixed meal tolerance test
Experimental: kisspeptin-10; kisspeptin infusion	Drug: Kisspeptin-10; kisspeptin-10 IV infusion; Other Names: kisspeptin; Other: mixed meal tolerance test; mixed meal tolerance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta-cell responsivity index	Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting insulin level	Average fasting insulin level comparing placebo and kisspeptin arms	up to 6 months

Collaborators and Investigators

• Sponsor: Stephanie B. Seminara, MD
• Investigators: Principal Investigator: Margaret Lippincott, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 21, 2024

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: kisspeptin; follicular phase
• Other Study ID Numbers: 267337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No