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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04958109
Other study ID # 267339
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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