Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

Study Overview

• Status: Recruiting
• Conditions: Metabolic Diseases
• Intervention / Treatment: Diagnostic test: Oral Glucose Tolerance Test; Drug: Kisspeptin; Drug: Placebo

Detailed Description

Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

• Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.

• During the inpatient study, the subjects will

  • Undergo a 16-hour kisspeptin infusion
  • Undergo an oral glucose tolerance test

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Margaret Lippincott, MD; Phone Number: 617-726-8434; Email: MGHKisspeptinResearch@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Margaret Lippincott, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

History:

• over the age of 18,
• normal pubertal development
• stable weight for previous three months,
• normal body mass index (BMI between 18.5-25)
• regular menstrual cycles

Physical examination:

• systolic BP < 140 mm Hg, diastolic < 90 mm Hg

Laboratory studies: (per MGH reference ranges)

• normal hemoglobin
• hemoglobin A1C < 6.5%
• BUN, creatinine not elevated
• AST, ALT < 3x upper limit of normal

Exclusion Criteria:

• active illicit drug use,
• history of a medication reaction requiring emergency medical care,
• difficulty with blood draws.
• history of chronic disease, except well controlled thyroid disease,
• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
• history of diabetes in a first degree relative,
• use of contraceptive pills, patches or vaginal rings within last 4 weeks.
• hyperlipidemia by fasting lipid panel
• positive serum pregnancy test (for all women)

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
Experimental: Kisspeptin; • Intravenous administration of kisspeptin 112-121 x 16 hours	Diagnostic test: Oral Glucose Tolerance Test; Administration of a 75 gm oral glucose tolerance test; Drug: Kisspeptin; Intravenous administration of kisspeptin 112-121 x 16 hours
Placebo Comparator: Placebo; • Intravenous administration of placebo x 16 hours	Diagnostic test: Oral Glucose Tolerance Test; Administration of a 75 gm oral glucose tolerance test; Drug: Placebo; Intravenous administration of Placebo 16 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Difference in Oral glucose Sensitivity Index (Kisspeptin-Placebo)	Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in OGTT	2 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Margaret Lippincott, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 12, 2021

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

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 267339

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