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

Metabolic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958109
• Other study ID #: 267339
• Status: Recruiting
• Phase: Phase 1
• Start date: October 28, 2021
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: Margaret Lippincott, MD
• 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 oral glucose tolerance test

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Diseases

Intervention

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
Intravenous administration of Placebo 16 hours

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