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Trial · Interventional

WithdrawnPhase 1Registry data

Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

NCTNCT05456854 (opens ClinicalTrials.gov in a new tab)Other id267335
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Overview

Status
Withdrawn
Phase
Phase 1
Enrollment
0 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
3 Jun 2022
Primary completion
1 Aug 2024 (estimated)
Completion
1 Aug 2024 (estimated)
First posted
13 Jul 2022
Last update posted
14 Aug 2024
Conditions
Metabolic Disease

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 1

    Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

    NCT05456854

    3 Jun 2022 to est. 1 Aug 2024

    Withdrawn

Registry summary

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

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

Interventions

  • Hyperglycemic ClampDiagnostic test
  • Kisspeptin-10Drug
  • PlaceboDrug

Arms2

  • Experimental

    Kisspeptin

    Intravenous administration of kisspeptin 112-121 x 16 hours

  • Placebo comparator

    Placebo

    Intravenous administration of placebo x 16 hours

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. First Phase Insulin Secretion

    Time frame · 10 minutes

    Registry description

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

  2. Second Phase Insulin Secretion

    Time frame · 2 hours

    Registry description

    Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo 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
* 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

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