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

NCT ID: NCT04532801

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2024-12-21

Brief Summary

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.

Detailed 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

Conditions

Insulin; Glucose; Healthy Volunteers; Women; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

kisspeptin-10

kisspeptin infusion

Group Type: EXPERIMENTAL

Kisspeptin-10

Intervention Type: DRUG

kisspeptin-10 IV infusion

mixed meal tolerance test

Intervention Type: OTHER

mixed meal tolerance test

placebo

placebo

Group Type: PLACEBO_COMPARATOR

mixed meal tolerance test

Intervention Type: OTHER

mixed meal tolerance test

Interventions

Kisspeptin-10

kisspeptin-10 IV infusion

Intervention Type: DRUG

mixed meal tolerance test

mixed meal tolerance test

Intervention Type: OTHER

Other Intervention Names

kisspeptin

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stephanie B. Seminara, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Margaret Lippincott, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

267337

Identifier Type: -

Identifier Source: org_study_id