Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance

Stephanie B. Seminara, MD

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers; Insulin; Glucose; Women; Pregnancy

Treatments: Drug: Kisspeptin-10; Other: mixed meal tolerance test

Study type: Interventional

Funder types: Other

Identifiers

NCT04532801

267337

Details and patient eligibility

About

This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.

Full description

Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.

Delivery of Interventions:

Prior to each visit, study subjects will be asked to:

• eat at least 150 gm carbohydrates per day
• refrain from strenuous exercise

On the day of the visit, study subjects will:

• eat a standardized meal prepared by the metabolic kitchen in the clinical research center
• be observed overnight to ensure a 12-hour fast
• have an IV placed, for a 16 hour kisspeptin or placebo infusion
• after the 12 hour fast, starting at 8 am in the morning will undergo a mixed meal tolerance test

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

HISTORY

• no personal history of chronic disease, except well controlled thyroid disease
• no history of diabetes in a first degree relative, including gestational diabetes
• no family or personal history of hyperlipidemia
• normal timing of menarche (age 10-14)
• normal menstrual cycles (q25-35 days)
• no use of contraceptive pills, patches or vaginal rings within last 4 weeks
• nulliparous (no history of a pregnancy)
• no active illicit drug use
• no history of a medication reaction requiring emergency medical care
• no difficulty with blood draws
• stable weight for previous three months
• available for all parts of the study

PHYSICAL

• body mass index (18.5-25)
• systolic BP < 120mm Hg, diastolic < 80 mm Hg
• normal waist circumference (less than 32 inches)

LABORATORY STUDIES: (per Massachusetts General Hospital reference ranges)

• fasting LDL cholesterol less than 130 mg/dL
• fasting triglycerides less than 150 mg/dL
• normal hemoglobin
• hemoglobin A1C < 5.7%
• blood urea nitrogen, creatinine not elevated
• AST, ALT not elevated
• negative serum pregnancy test

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-10

Experimental group

Description:

kisspeptin infusion

Treatment:

Other: mixed meal tolerance test

Drug: Kisspeptin-10

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Other: mixed meal tolerance test