Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

NCT ID: NCT05456854

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2024-08-01

Brief Summary

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

Detailed Description

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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

Conditions

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Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Kisspeptin

Intravenous administration of kisspeptin 112-121 x 16 hours

Group Type EXPERIMENTAL

Hyperglycemic Clamp

Intervention Type DIAGNOSTIC_TEST

Administration of a hyperglycemic clamp

Kisspeptin-10

Intervention Type DRUG

Administration of kisspeptin-10 \* 16 hr

Placebo

Intravenous administration of placebo x 16 hours

Group Type PLACEBO_COMPARATOR

Hyperglycemic Clamp

Intervention Type DIAGNOSTIC_TEST

Administration of a hyperglycemic clamp

Placebo

Intervention Type DRUG

Administration of placebo \*16 hr

Interventions

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Hyperglycemic Clamp

Administration of a hyperglycemic clamp

Intervention Type DIAGNOSTIC_TEST

Kisspeptin-10

Administration of kisspeptin-10 \* 16 hr

Intervention Type DRUG

Placebo

Administration of placebo \*16 hr

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret Lippincott

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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267335

Identifier Type: -

Identifier Source: org_study_id

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