What side effects are associated with this type of intervention?

Common treatments for diabetes that impact beta-cell function and insulin secretion include GLP-1 receptor agonists and DPP-4 inhibitors. GLP-1 receptor agonists, such as liraglutide and semaglutide, are associated with gastrointestinal side effects like nausea and vomiting, and there is a potential risk for pancreatitis and pancreatic cancer. DPP-4 inhibitors, such as sitagliptin and saxagliptin, generally have a favorable safety profile but may also carry a risk of pancreatitis. Both classes of drugs have shown beneficial effects on glycemic control and weight loss.

What prior FDA approvals exist?

The FDA has approved several incretin-based therapies for the treatment of type 2 diabetes, which focus on enhancing beta-cell function and insulin secretion. Notable approvals include GLP-1 receptor agonists such as liraglutide (approved for children ≥10 years) and extended-release exenatide (approved for children 10 to 17 years). These drugs have shown efficacy in improving glycemic control and are often used as adjuncts to metformin therapy. Additionally, dulaglutide has been approved for similar age groups and has demonstrated significant improvements in glycemic control. These therapies are relevant to the study of kisspeptin's impact on beta-cell function and insulin secretion.

What other types of research exist?

Promising alternatives to Kisspeptin infusion for diabetes treatment in 2024 include DPP-4 inhibitors (e.g., sitagliptin, saxagliptin, linagliptin) and GLP-1 receptor agonists (e.g., liraglutide, exenatide). These therapies have shown efficacy in preserving beta-cell function and improving insulin secretion.

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Hormone Therapy

Kisspeptin for Insulin Secretion in Healthy Women

Phase 1

Waitlist Available

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

Summary

This trial uses kisspeptin infusions to study their effect on blood sugar management in healthy women. Participants receive kisspeptin through an infusion. The goal is to see if kisspeptin helps the body release insulin more effectively after eating.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beta-cell responsivity index

Other study objectives

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes often target beta-cell function and insulin secretion to improve glycemic control. Kisspeptin infusion, for example, enhances insulin secretion by increasing beta-cell responsivity. Similarly, GLP-1 receptor agonists stimulate insulin release and inhibit glucagon secretion, thereby lowering blood glucose levels. DPP-IV inhibitors prolong the action of incretin hormones, which also boost insulin secretion and suppress glucagon. These mechanisms are crucial for diabetes patients as they directly address the underlying issues of insulin deficiency and glucose regulation, leading to better management of blood sugar levels and reduced risk of complications.

The Role of GLP-1 Signaling in Hypoglycemia due to Hyperinsulinism.Incretin action in the pancreas: potential promise, possible perils, and pathological pitfalls.Kisspeptin stimulation of insulin secretion: mechanisms of action in mouse islets and rats.