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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00459992 |
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:
Condition | Intervention | Phase |
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Obesity Overweight Overnutrition |
Drug: Betahistine Hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of the Metabolic Effects of Betahistine Hydrochloride (Obecure) in Overweight Women |
Estimated Enrollment: | 120 |
Study Start Date: | April 2007 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Volunteers will qualify if they meet the following criteria:
Willingness to participate in the research protocol.
EXCLUSION CRITERIA:
Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 070126, 07-CH-0126 |
Study First Received: | April 12, 2007 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00459992 History of Changes |
Health Authority: | United States: Federal Government |
Obesity Weight Gain Adult Histamine |
Metabolism Obesity Overweight |
Obesity Neurotransmitter Agents Vasodilator Agents Overweight Betahistine Cardiovascular Agents Weight Gain |
Histamine Body Weight Signs and Symptoms Nutrition Disorders Histamine phosphate Overnutrition |
Obesity Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Overweight Betahistine |
Cardiovascular Agents Pharmacologic Actions Body Weight Signs and Symptoms Histamine Agonists Therapeutic Uses Nutrition Disorders Overnutrition |