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

Primary Purpose

Metabolic Diseases

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral Glucose Tolerance Test
Kisspeptin
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Diseases

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

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

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2021
Last Updated
July 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04958109
Brief Title
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
Official Title
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 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 oral glucose tolerance test
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 an oral glucose tolerance test

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (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)
Oral Glucose Tolerance Test
Intervention Description
Administration of a 75 gm oral glucose tolerance test
Intervention Type
Drug
Intervention Name(s)
Kisspeptin
Intervention Description
Intravenous administration of kisspeptin 112-121 x 16 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous administration of Placebo 16 hours
Primary Outcome Measure Information:
Title
Average Difference in Oral glucose Sensitivity Index (Kisspeptin-Placebo)
Description
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in OGTT
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Lippincott, MD
Phone
617-726-8434
Email
MGHKisspeptinResearch@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Lippincott, MD
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, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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