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Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Primary Purpose

Metabolic Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperglycemic Clamp
Kisspeptin-10
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Disease

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers
  • 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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kisspeptin

Placebo

Arm Description

Intravenous administration of kisspeptin 112-121 x 16 hours

Intravenous administration of placebo x 16 hours

Outcomes

Primary Outcome Measures

First Phase Insulin Secretion
Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Second Phase Insulin Secretion
Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms

Secondary Outcome Measures

Full Information

First Posted
July 8, 2022
Last Updated
July 12, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05456854
Brief Title
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Official Title
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kisspeptin
Arm Type
Experimental
Arm Description
Intravenous administration of kisspeptin 112-121 x 16 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous administration of placebo x 16 hours
Intervention Type
Diagnostic Test
Intervention Name(s)
Hyperglycemic Clamp
Intervention Description
Administration of a hyperglycemic clamp
Intervention Type
Drug
Intervention Name(s)
Kisspeptin-10
Intervention Description
Administration of kisspeptin-10 * 16 hr
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of placebo *16 hr
Primary Outcome Measure Information:
Title
First Phase Insulin Secretion
Description
Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Time Frame
10 minutes
Title
Second Phase Insulin Secretion
Description
Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Time Frame
2 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Lippincott
Phone
617-726-8434
Email
MGHKisspeptinResearch@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Lippincott
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Lippincott

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

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