Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Metabolic Disease Clinical Trial

Official title:

Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456854
• Other study ID #: 267335
• Status: Recruiting
• Phase: Phase 1
• Start date: June 3, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: Margaret Lippincott
• Phone: 617-726-8434
• Email: MGHKisspeptinResearch[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

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 a hyperglycemic clamp

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

• over the age of 17

• normal pubertal development

• regular menstrual cycles

• stable weight for previous three months

• normal body mass index

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

• normal hemoglobin

• hemoglobin A1C < 6.5%

• BUN, creatinine not elevated

• AST, ALT < 3x upper limit of normal

• negative serum pregnancy test

Exclusion Criteria:

• active illicit drug use,

• history of a medication reaction requiring emergency medical care,

• difficulty with blood draws.

• history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.

• history of chronic disease that has required hospitalization

• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control

• history of diabetes in a first degree relative

• hyperlipidemia by fasting lipid panel

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases

Intervention

Diagnostic Test:
• Hyperglycemic Clamp
Administration of a hyperglycemic clamp

Drug:
• Kisspeptin-10
Administration of kisspeptin-10 * 16 hr
• Placebo
Administration of placebo *16 hr

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Phase Insulin Secretion	Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms	10 minutes
Primary	Second Phase Insulin Secretion	Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms	2 hours