Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

Mass General Brigham

Status and phase: Withdrawn; Phase 1

Conditions: Metabolic Disease

Treatments: Diagnostic Test: Hyperglycemic Clamp; Drug: Placebo; Drug: Kisspeptin-10

Study type: Interventional

Funder types: Other

Identifiers

NCT05456854

267335

Details and patient eligibility

About

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

Full description

Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.

During the inpatient study, the subjects will

Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• over the age of 17
• normal pubertal development
• regular menstrual cycles
• stable weight for previous three months
• normal body mass index
• blood pressure systolic BP < 140 mm Hg, diastolic < 90 mm Hg
• normal hemoglobin
• hemoglobin A1C < 6.5%
• BUN, creatinine not elevated
• AST, ALT < 3x upper limit of normal
• negative serum pregnancy test

Exclusion Criteria:

• active illicit drug use,
• history of a medication reaction requiring emergency medical care,
• difficulty with blood draws.
• history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
• history of chronic disease that has required hospitalization
• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
• history of diabetes in a first degree relative
• hyperlipidemia by fasting lipid panel

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Kisspeptin

Experimental group

Description:

Intravenous administration of kisspeptin 112-121 x 16 hours

Treatment:

Drug: Kisspeptin-10

Diagnostic Test: Hyperglycemic Clamp

Placebo

Placebo Comparator group

Description:

Intravenous administration of placebo x 16 hours

Treatment:

Drug: Placebo

Diagnostic Test: Hyperglycemic Clamp