Effects of Betahistine Hydrochloride in Overweight Women
Condition: Obesity; Overweight; Overnutrition
MeSH terms: Overweight; Overnutrition
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Betahistine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Obesity; Weight Gain; Adult; Histamine; Metabolism; Overweight