Effects of Betahistine Hydrochloride in Overweight Women
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|ClinicalTrials.gov Identifier: NCT00459992|
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : May 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight Overnutrition||Drug: Betahistine Hydrochloride||Phase 1|
Current medications for the long-term treatment of obesity are moderately effective at best. Therefore, research focusing on compounds that affect energy balance through novel mechanisms is warranted. Preliminary human and animal data suggest central nervous system histaminergic tone is important in the regulation of food intake. We therefore propose to study the effects of betahistine hydrochloride, a histamine analogue which has agonist activity at the histaminergic H1 receptor and antagonist/reverse agonist activity at the H3 receptor. Prior animal studies have suggested that betahistine suppresses food intake and reduces body weight, but there are sparse human data assessing the effects of betahistine on metabolism.
Betahistine s effects on women s food intake and metabolism will be evaluated through an inpatient randomized double-blind placebo controlled dose-ranging study. We will examine the acute effects of betahistine on food intake, hunger, and satiety, resting energy expenditure, and on hormones and substrates relevant for body weight regulation. If results suggest betahistine has salutary effects on food intake or metabolism in humans, these studies will lay the groundwork for additional investigations to assess the efficacy of betahistine in the treatment of obesity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pilot Study of the Metabolic Effects of Betahistine Hydrochloride in Overweight Women|
|Study Start Date :||April 10, 2007|
|Actual Primary Completion Date :||February 14, 2011|
|Actual Study Completion Date :||February 14, 2011|
- Changes in food intake and appetite with betahistine treatment.
- Gut hormone assessment with betahistine treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459992
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jack A Yanovski, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|