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Hormone Therapy

Kisspeptin for Insulin Secretion in Healthy Women

Phase 1
Recruiting
Led By Margaret Lippincott, MD
Research Sponsored by Stephanie B. Seminara, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal waist circumference (less than 32 inches)
No personal history of chronic disease, except well controlled thyroid disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial is studying if kisspeptin can help improve beta-cell responsivity in healthy women.

Who is the study for?
This trial is for healthy women without diabetes in their immediate family, no drug use or history of high cholesterol. Participants must have stable weight, normal blood pressure and waist size, and not be pregnant. They should have regular menstrual cycles, a BMI between 18.5-25, and no recent use of hormonal contraceptives.Check my eligibility
What is being tested?
The study tests the effect of kisspeptin (a naturally occurring hormone) on insulin production after eating a mixed meal. Healthy female participants will receive infusions of kisspeptin to see how it affects their body's response to food intake.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but could include reactions at the infusion site or hormonal changes due to kisspeptin administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My waist is less than 32 inches.
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I have no chronic diseases, except for well-controlled thyroid disease.
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I have no issues with having my blood drawn.
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None of my close family members have had diabetes.
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I do not have a family or personal history of high cholesterol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beta-cell responsivity index
Other outcome measures
Fasting insulin level

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: kisspeptin-10Experimental Treatment2 Interventions
kisspeptin infusion
Group II: placeboPlacebo Group1 Intervention
placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kisspeptin-10
2013
Completed Phase 3
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor
9 Previous Clinical Trials
1,315 Total Patients Enrolled
Margaret Lippincott, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
429 Total Patients Enrolled

Media Library

Kisspeptin-10 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04532801 — Phase 1
Diabetes Research Study Groups: placebo, kisspeptin-10
Diabetes Clinical Trial 2023: Kisspeptin-10 Highlights & Side Effects. Trial Name: NCT04532801 — Phase 1
Kisspeptin-10 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04532801 — Phase 1

Frequently Asked Questions

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

Does this study permit me to become a participant?

"To be considered for inclusion in this trial, female candidates aged between 18 and 40 are sought after. The team is hoping to enroll 25 suitable participants."

Answered by AI

Are there other experiments that made use of Kisspeptin-10?

"Currently, there is 1 active trial for Kisspeptin-10 in Phase 3. Boston, Massachusetts is hosting multiple studies on the subject and there are other research sites across the US that have joined in this scientific effort."

Answered by AI

Approximately how many participants are being included in this clinical experiment?

"Correct. Information hosted on clinicaltrials.gov verifies that this medical experiment, which was initially shared on September 1st 2019, is actively searching for participants. 25 patients should be enrolled from a single site."

Answered by AI

Can you detail the safety parameters of Kisspeptin-10 for human use?

"Taking into account the limited data for efficacy and safety, our team at Power assigned Kisspeptin-10 a score of 1 on a scale from one to three."

Answered by AI

Is enrollment currently open for this medical investigation?

"Affirmative. According to the information located on clinicaltrials.gov, this research study is currently enrolling participants at a single site and requires 25 individuals in total. It was first posted back on September 1st 2019, with its most recent update being made July 19th 2022."

Answered by AI

Is the age criterion for this clinical trial flexible enough to include individuals aged 45 and over?

"As denoted by the trial's inclusion criteria, only those aged between 18 and 40 can register for this clinical study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
Stephanie B. Seminara, MD 2019. "Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04532801.
~2 spots leftby Aug 2024
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