Efficacy Study of Betahistine on Body Weight in Obese Female Subjects
Summary
The purpose of this study is to examine the effect of betahistine on body weight in obese female subjects
Description
This is a randomized, double-blind, placebo-controlled, dose finding, multicenter study. The study will consist of 3 treatment groups (48 mg/day, 96 mg/day, and matching placebo). Approximately 180 subjects (60 per treatment group) will be randomized into this 12-week study.
A screening visit will be used to determine subject suitability for inclusion in the trial.
One week after the screening visit subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following treatment groups:
- Betahistine 24 mg twice a day (BID) (48 mg/day total),
- Betahistine 48 mg BID (96 mg/day total),
- Matching placebo.
All subjects will be prescribed a nutritionally balanced mildly hypocaloric diet. The prescribed diet will contain approximately 30% of calories from fat, 50% of calories from carbohydrates, and 20% of calories from protein. The individual subject's estimated total daily energy expenditure minus 600 kcal will be used to determine each subject's daily caloric intake value during the study. The total daily energy expenditure will be estimated for each subject from the basal energy expenditure multiplied by a correction factor of 1.3 to account for the amount of energy needed in mild to moderate daily activity for obese subjects.
Double-blind treatment will continue for 12 weeks. Study medication (betahistine and/or matching placebo) will be orally administered BID about 1-2 hrs prior to meals (at 10:00 and at 17:00). During this period, 4 additional study visits (at 2, 4, 8, and 12 weeks) will take place.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Obesity
Intervention
betahistine dihydrochloride, betahistine dihydrochloride, placebo
Location
GP: Dr. Van Mulders
Aalst
Belgium
9310
Status
Completed
Source
OBEcure Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00748436
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Trans-1,4-bis(2-chlorobenzaminomethyl)cyclohexane Dihydrochlorid...
An anticholesteremic agent that inhibits sterol biosynthesis in animals.
Betahistine
A histamine analog and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.
Obesity, Abdominal
A condition of having excess fat in the abdomen. Abdominal obesity is typically defined as waist circumferences of 40 inches or more in men and 35 inches or more in women. Abdominal obesity raises the risk of developing disorders, such as diabetes, hypertension and METABOLIC SYNDROME X.
Obesity, Morbid
The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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