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Peptide Hormone

Kisspeptin for Metabolic Diseases

Phase 1
Recruiting
Led By Margaret Lippincott
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
over the age of 17
normal pubertal development
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes
Awards & highlights

Study Summary

This trial looks at how the hormone kisspeptin affects metabolism and blood sugar levels.

Who is the study for?
This trial is for individuals over 17 with normal blood counts, kidney and liver function, regular menstrual cycles (if applicable), stable weight, a healthy body mass index, and normal blood pressure. They must not have chronic diseases requiring hospitalization or be taking metabolism-affecting drugs recently.Check my eligibility
What is being tested?
The study aims to understand how kisspeptin (a hormone) affects metabolism by using a hyperglycemic clamp technique to measure insulin response. Participants will receive either Kisspeptin-10 or a placebo in this controlled experiment.See study design
What are the potential side effects?
Potential side effects of kisspeptin administration are not detailed here but may include reactions at the injection site, hormonal changes affecting mood or appetite, and possible alterations in glucose levels due to its metabolic role.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 17.
Select...
My puberty development was normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
First Phase Insulin Secretion
Second Phase Insulin Secretion

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KisspeptinExperimental Treatment2 Interventions
Intravenous administration of kisspeptin 112-121 x 16 hours
Group II: PlaceboPlacebo Group2 Interventions
Intravenous administration of placebo x 16 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kisspeptin-10
Not yet FDA approved
Hyperglycemic Clamp
2018
Completed Phase 4
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,469 Total Patients Enrolled
6 Trials studying Metabolic Diseases
584 Patients Enrolled for Metabolic Diseases
Margaret LippincottPrincipal InvestigatorMassachusetts General Hospital

Media Library

Kisspeptin-10 (Peptide Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05456854 — Phase 1
Metabolic Diseases Research Study Groups: Placebo, Kisspeptin
Metabolic Diseases Clinical Trial 2023: Kisspeptin-10 Highlights & Side Effects. Trial Name: NCT05456854 — Phase 1
Kisspeptin-10 (Peptide Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456854 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this research endeavor?

"Affirmative, the clinical trial is still open for recruitment. According to data available on clinicaltrials.gov, this study was first published on June 3rd 2022 and its details were last modified on July 12th 2022. This research has a requirement of 12 participants from one site."

Answered by AI

How has Hyperglycemic Clamp been assessed for its safety in human patients?

"Hyperglycemic Clamp is a relatively untested therapeutic intervention, so it only received a score of 1 due to the lack of data regarding its efficacy and safety."

Answered by AI

Does the criteria for this research encompass participants over 50 years of age?

"This clinical trial is open to individuals between 18 and 40 years of age. There are separate trials for those under the legal voting age as well as one specifically tailored towards seniors above 65."

Answered by AI

Who is eligible to become a participant of this research?

"Eligible participants in this trial must be under 40 years of age and suffering from a metabolic disorder. Additional requirements include being 17 or older, normal pubertal development, regular menstrual cycles, stable weight within the last three months, BMI below average values for their height and sex (systolic BP < 140 mm Hg/diastolic < 90 mm Hg), hemoglobin level within the physiological range (A1C < 6.5%), creatinine not elevated above baseline levels as well as AST & ALT concentrations lower than 3 times upper limit of normative figures."

Answered by AI

Does this research project currently have open enrollment?

"Indeed, the information on clinicaltrials.gov reveals that this research is currently enrolling patients. Initially posted on June 3rd 2022 and last modified on July 12th 2022, it seeks to recruit a total of twelve participants from one location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Stephanie B. Seminara, MD 2022. "Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05456854.
~1 spots leftby Aug 2024
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