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Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

Sponsor
Stephanie B. Seminara, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT04532801
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
51.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.

Delivery of Interventions:
Prior to each visit, study subjects will be asked to:

  • eat at least 150 gm carbohydrates per day

  • refrain from strenuous exercise

On the day of the visit, study subjects will:

  • eat a standardized meal prepared by the metabolic kitchen in the clinical research center

  • be observed overnight to ensure a 12-hour fast

  • have an IV placed, for a 16 hour kisspeptin or placebo infusion

  • after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
physiologic studiesphysiologic studies
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: kisspeptin-10

kisspeptin infusion

Drug: Kisspeptin-10
kisspeptin-10 IV infusion
Other Names:
  • kisspeptin

    • Other: mixed meal tolerance test
    mixed meal tolerance test
    Placebo Comparator: placebo

    placebo

    Other: mixed meal tolerance test
    mixed meal tolerance test

    Outcome Measures

    Primary Outcome Measures

    1. Beta-cell responsivity index [up to 6 months]

      Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms

    Other Outcome Measures

    1. Fasting insulin level [up to 6 months]

      Average fasting insulin level comparing placebo and kisspeptin arms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    HISTORY

    • no personal history of chronic disease, except well controlled thyroid disease

    • no history of diabetes in a first degree relative, including gestational diabetes

    • no family or personal history of hyperlipidemia

    • normal timing of menarche (age 10-14)

    • normal menstrual cycles (q25-35 days)

    • no use of contraceptive pills, patches or vaginal rings within last 4 weeks

    • nulliparous (no history of a pregnancy)

    • no active illicit drug use

    • no history of a medication reaction requiring emergency medical care

    • no difficulty with blood draws

    • stable weight for previous three months

    • available for all parts of the study

    PHYSICAL

    • body mass index (18.5-25)

    • systolic BP < 120mm Hg, diastolic < 80 mm Hg

    • normal waist circumference (less than 32 inches)

    LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)

    • fasting LDL cholesterol less than 130 mg/dL

    • fasting triglycerides less than 150 mg/dL

    • normal hemoglobin

    • hemoglobin A1C < 5.7%

    • blood urea nitrogen, creatinine not elevated

    • AST, ALT not elevated

    • negative serum pregnancy test

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Stephanie B. Seminara, MD

    Investigators

    • Principal Investigator: Margaret Lippincott, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04532801
    Other Study ID Numbers:
    • 267337
    First Posted:
    Aug 31, 2020
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
    kisspeptin
    follicular phase

    Study Results

    No Results Posted as of Jul 21, 2022