Insulin, Glucose, Healthy Volunteers, Women, Pregnancy
Conditions
Keywords
kisspeptin, follicular phase
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
Interventions
DRUGKisspeptin-10
kisspeptin-10 IV infusion
mixed meal tolerance test
Sponsors
Stephanie B. Seminara, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
physiologic studies
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beta-cell responsivity index | up to 6 months | Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fasting insulin level | up to 6 months | Average fasting insulin level comparing placebo and kisspeptin arms |
Countries
United States
Outcome results
None listed