Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

Mass General Brigham

Status and phase: Completed; Phase 1

Conditions: Metabolic Diseases

Treatments: Drug: Placebo; Drug: Kisspeptin; Diagnostic Test: Oral Glucose Tolerance Test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04958109

267339

5K23HD097296 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

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 an oral glucose tolerance test

Enrollment: 16 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

History:

• over the age of 18,
• normal pubertal development
• stable weight for previous three months,
• normal body mass index (BMI between 18.5-25)
• regular menstrual cycles

Physical examination:

• systolic BP < 140 mm Hg, diastolic < 90 mm Hg

Laboratory studies: (per Massachusetts General Hospital reference ranges)

• normal hemoglobin
• hemoglobin A1C < 6.5%
• blood urea nitrogen, creatinine not elevated
• aspartate aminotransferase, alanine aminotransferase < 3x upper limit of normal

Exclusion criteria

• active illicit drug use,
• history of a medication reaction requiring emergency medical care,
• difficulty with blood draws.
• history of chronic disease, except well controlled thyroid disease,
• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
• history of diabetes in a first degree relative,
• use of contraceptive pills, patches or vaginal rings within last 4 weeks.
• hyperlipidemia by fasting lipid panel
• positive serum pregnancy test (for all women)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Kisspeptin

Experimental group

Description:

• Intravenous administration of kisspeptin 112-121 x 16 hours

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test

Drug: Kisspeptin

Placebo

Placebo Comparator group

Description:

• Intravenous administration of placebo x 16 hours

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test

Drug: Placebo