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Trial · Interventional

WithdrawnPhase 1Registry data

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

NCTNCT04532801 (opens ClinicalTrials.gov in a new tab)Other id267337
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 1
Enrollment
0 participants (actual)
Sponsor
Stephanie B. Seminara, MD · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
1 Sept 2019
Primary completion
31 Aug 2024 (estimated)
Completion
21 Dec 2024 (estimated)
First posted
31 Aug 2020
Last update posted
1 Aug 2024
Conditions
Insulin · Glucose · Healthy Volunteers · Women · Pregnancy

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022202320242025
  1. Ph 1

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

    NCT04532801

    1 Sept 2019 to est. 21 Dec 2024

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Kisspeptin-10Drug
  • mixed meal tolerance testOther

Arms2

  • Experimental

    kisspeptin-10

    kisspeptin infusion

  • Placebo comparator

    placebo

    placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Beta-cell responsivity index

    Time frame · up to 6 months

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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