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Peptide

Kisspeptin for Diabetes Control

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 pubertal development
No recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights

Study Summary

This trial looks at how a protein called kisspeptin might help control blood sugar and insulin levels.

Who is the study for?
This trial is for adults with stable weight, normal BMI (18.5-25), no severe medication reactions, and no first-degree relatives with diabetes. Participants must not use certain medications or have chronic diseases except controlled thyroid issues. They should have hypogonadism or prediabetes but not full-blown diabetes, well-controlled blood pressure, and no history of cancer (except some skin cancers) in the last 5 years.Check my eligibility
What is being tested?
The study examines kisspeptin's effect on blood sugar control by comparing it to a placebo. It includes an insulin resistance test to see how well the body uses insulin. The goal is to understand if kisspeptin can improve glucose levels in those with low testosterone or prediabetes.See study design
What are the potential side effects?
Potential side effects are not detailed here but could include reactions related to hormone changes such as mood swings, acne, or injection site discomfort since kisspeptin influences reproductive hormones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My puberty development was normal.
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I haven't taken any drugs recently that affect metabolism or reproduction, except for thyroid or allergy meds.
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None of my immediate family has diabetes.
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I have been diagnosed with low testosterone.
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I can stop my hormone therapy for a specified time if needed.
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My hemoglobin levels are normal, or slightly low if I have low sex hormone levels.
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I have no issues with having my blood drawn.
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I have no chronic diseases, except for my thyroid condition which is under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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 area under the curve of insulin in response to a mixed meal tolerance test
Secondary outcome measures
Average difference in area under the curve of glucagon-like peptide 1 in response to a mixed meal tolerance test
Average difference in area under the curve of glucose in response to a mixed meal tolerance test

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Kisspeptin and Insulin Resistance TestExperimental Treatment2 Interventions
Intravenous (IV) administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
Group II: Placebo and Insulin Resistance TestPlacebo Group2 Interventions
IV administration of fluids that contain no study drug; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
kisspeptin 112-121
2013
Completed Phase 1
~120

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
927 Total Patients Enrolled
Margaret Lippincott, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Kisspeptin 112-121 (Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT02953834 — Phase 1
Prediabetes Research Study Groups: Kisspeptin and Insulin Resistance Test, Placebo and Insulin Resistance Test
Prediabetes Clinical Trial 2023: Kisspeptin 112-121 Highlights & Side Effects. Trial Name: NCT02953834 — Phase 1
Kisspeptin 112-121 (Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02953834 — Phase 1

Frequently Asked Questions

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

Can kisspeptin 112-121 be utilized without risking harm to patients?

"Despite the lack of substantial efficacy and safety data, kisspeptin 112-121 has been assigned a score of 1. This indicates that it is in its earliest phase of clinical trial development."

Answered by AI

What is the size of the participant pool for this medical experiment?

"Affirmative. Details on clinicaltrials.gov attest to the fact that this medical study, which was originally published June 6th 2017, is currently recruiting individuals. A total of 413 participants need to be enrolled from 1 trial centre."

Answered by AI

What conditions must be satisfied for someone to join this research?

"In order to be considered for this clinical trial, potential participants must have impaired glucose tolerance and be between the ages of 18-60. A total of 413 individuals are being recruited that meet these criteria."

Answered by AI

Are there any openings for partakers in this research?

"Affirmative. The clinicaltrials.gov database indicates that this investigation is actively seeking participants, having been posted on June 6th 2017 and recently updated on June 29th 2022. The project requires 413 patients to be recruited from one medical site."

Answered by AI

Are there other research papers which have examined the effects of kisspeptin 112-121?

"At the present moment, there is 71 ongoing investigations into kisspeptin 112-121. Of those studies, 13 are in the advanced Phase 3 testing stage. Most of these experiments take place within Cincinnati, Ohio but they span 247 different sites around the globe."

Answered by AI

Does this trial embrace geriatric populations?

"To be eligible to join this study, patients need to fall in the 18-60 age range. Conversely, there are 21 clinical trials for youth and 179 studies that cater towards seniors."

Answered by AI

Who else is applying?

What state do they live in?
Maine
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~20 spots leftby Aug 2024