Clinical trial NCT04532801: Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
Official title: Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Insulin
Glucose
Healthy Volunteers
Women
Pregnancy
Keywords: kisspeptin
follicular phase
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: physiologic studies
Primary purpose: OTHER

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

Eligibility 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

Primary outcomes:
measure: Beta-cell responsivity index
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
measure: Fasting insulin level
timeFrame: up to 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margaret Lippincott, MD
role: PRINCIPAL_INVESTIGATOR
References: