Effects of Betahistine Hydrochloride in Overweight Women
Status:
Completed
Trial end date:
2011-02-14
Target enrollment:
Participant gender:
Summary
This study will evaluate the effects of a drug called betahistine on appetite and food intake
in overweight women. Betahistine has been used for many years to treat vertigo (dizziness).
It was taken off the market in the United States in 1970 because it was thought to be
ineffective for vertigo, but is still used for this purpose in many other countries. Some
research suggests that betahistine may reduce appetite and food intake.
Healthy overweight women between 18 and 50 years of age may be eligible for this study.
Candidates must have a body mass index (BMI) between 30 and 40 and weigh less than 300
pounds. They are screened with a medical history and physical examination, blood and urine
tests, electrocardiogram (EKG), breathing test and eating behavior questionnaires.
Participants are admitted to the NIH Clinical Center for a 3-day/2-night stay for the
following procedures:
- Medication: Subjects take either betahistine (in one of three possible doses) or placebo
capsules one time on the days of admission to the Clinical Center (day 1), three times
on day 2 and two times on day 3.
- Blood tests and 24-hour urine collection.
- Resting metabolic rate: Subjects rest quietly for 1 hour after awakening and then rest
again under a clear plastic hood or while wearing a face mask, breathing normally for
about 25 minutes.
- DEXA scan to measure body fat, muscle, and bone mineral content: Subjects lie on a table
above a source of X-rays while a very small dose of X-rays is passed through the body.
- Meal studies: Subjects food intake is measured on days 2 and 3.
- Questionnaires: Subjects complete questionnaires about how hungry or full they are
feeling and rate how much they liked the foods they ate.
Phase:
Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)