Effects of Betahistine Hydrochloride in Overweight Women

Completed · Phase 1

Conditions studied: Obesity, Overweight, Overnutrition

In brief

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.

Key facts

Study ID

NCT00459992

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

150

Starts

2007-04-10

Expected to finish

2011-02-14

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
• A presence of major illnesses: renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism, pheochromocytoma), hematological problems or pulmonary disorders; or porphyria;
• History of anaphylaxis, asthma, urticaria, rhinitis, allergic rash, or other allergic disease requiring antihistamine treatment; subjects with a history of antihistamine treatment for a self-limited allergic reaction such as to poison ivy or to a medication that they are no longer taking may be included at the discretion of the primary investigator.
• History of peptic ulcer disease;
• Baseline QT interval prolongation (greater than or equal to 480 msec QTc) because of reports of histaminergic compounds causing prolonged QT interval and cardiac arrhythmias in susceptible patients (i.e. those with prolonged QT interval at baseline);
• Current smokers of tobacco products;
• Self-reported lactose intolerance;
• Self-reported food allergy to foods used in standardized food array in this protocol or to betahistine itself;
• Subjects following a diet with specific food requirements such as vegetarian, vegan, or kosher because of the use of a standardized food array in this protocol;
• Subjects with a history of DSMIV classifiable eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder will be excluded from the current proof-of-concept study;
• Women with reproductive potential who are pregnant or who are currently nursing an infant;
• Individuals who have current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study;
• Subjects who regularly use prescription medications unrelated to the complications of obesity (especially vasoactive compounds such as calcium channel blockers, nitrates, beta-blockers, etc.), subjects using H2 blockers for dyspepsia, and subjects who require chronic use of antihistamines for allergic conditions; oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication for at least 3 months prior to study entry may be eligible. Allowable medications may include statins for the treatment of dyslipidemia and low-dose aspirin for primary prevention of acute coronary syndrome. Medications used for the treatment of hypertension will not be allowed because of the potential vasodilatory activity of betahistine.
• Recent (3 months) use of anorexiant medications;
• Weight change of more than 3% of body weight in the past two months;
• Subjects with a consistently (2 weeks apart) elevated systolic blood pressure of greater than 160 mm Hg and/or a diastolic blood pressure greater than 95 mm Hg.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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