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Hormone Therapy

Kisspeptin for Metabolic Diseases

Phase 1
Recruiting
Led By Margaret Lippincott, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
regular menstrual cycles
normal pubertal development
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights

Study Summary

This trial will study how the hormone kisspeptin affects metabolism, by testing subjects' responses to an oral glucose tolerance test.

Who is the study for?
This trial is for adults over 18 with normal blood pressure, kidney and liver function, stable weight, no diabetes in close family, and women must not be pregnant. Participants should have a healthy BMI (18.5-25), regular menstrual cycles if female, and controlled thyroid disease is okay.Check my eligibility
What is being tested?
The study tests how kisspeptin affects the body's response to sugar by using an oral glucose tolerance test compared to a placebo. The goal is to understand kisspeptin's role in metabolism.See study design
What are the potential side effects?
Potential side effects are not detailed but may include reactions similar to other hormonal treatments such as changes in appetite, mood swings, or injection site discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have regular menstrual cycles.
Select...
My puberty development was normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Difference in Oral glucose Sensitivity Index (Kisspeptin-Placebo)

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
Oral Glucose Tolerance Test
2019
Completed Phase 4
~840

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
2,931 Previous Clinical Trials
13,198,429 Total Patients Enrolled
6 Trials studying Metabolic Diseases
580 Patients Enrolled for Metabolic Diseases
Margaret Lippincott, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
438 Total Patients Enrolled

Media Library

Kisspeptin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04958109 — Phase 1
Metabolic Diseases Research Study Groups: Kisspeptin, Placebo
Metabolic Diseases Clinical Trial 2023: Kisspeptin Highlights & Side Effects. Trial Name: NCT04958109 — Phase 1
Kisspeptin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958109 — Phase 1

Frequently Asked Questions

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

Are any fresh participants being admitted to this clinical trial presently?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively searching for test subjects and was initially posted on October 28th 2021 with the latest update occurring June 29th 2022. 16 participants need to be sourced from one site in total."

Answered by AI

What potential risks may be associated with undergoing an Oral Glucose Tolerance Test?

"The consensus among the Power team is that Oral Glucose Tolerance Test has a safety rating of 1, since it's only been tested in limited clinical trials and there is not much data supporting its efficacy."

Answered by AI

How many participants are registering for the research project?

"Affirmative. In accordance with the information posted on clinicaltrials.gov, this trial is currently searching for 16 participants across a single site. The study was originally published on October 28th 2021 and last updated June 29th 2022."

Answered by AI

Is it feasible for me to take part in this clinical experiment?

"This medical experiment seeks 16 participants between 18 and 40 years old that are currently inflicted with metabolic diseases. Furthermore, each candidate must possess a normal pubertal development, have maintained their weight for the last 3 months, BMI of 18.5-25, regular menstrual cycle frequency, systolic BP lower than 140 mm Hg as well as diastolic BP under 90mmHg. Additionally laboratory tests should display standard hemoglobin levels and an A1C value below 6.5% along with non-elevated BUN/Creatinine results according to MGH reference ranges."

Answered by AI

Are elderly individuals eligible to participate in this trial?

"Adhering to the criteria for inclusion in this trial, patient must be at least 18 years old and cannot exceed 40."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
Stephanie B. Seminara, MD 2021. "Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04958109.
~1 spots leftby Aug 2024
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