Obesity Clinical Trial
Official title:
The Effects of Orlistat/Phentermine Versus Placebo/Phentermine Treatment on Weight Loss and Vascular Function of Overweight Patients With Back Pain
The prevalence of obesity is increasing worldwide and obesity is an important risk factor for
cardiovascular disease. In addition, back pain has been increasing steadily due to sitting
life, lack of exercise, wrong posture, and obesity. Recent studies found that obesity and
back pain are common diseases and are closely related to each other. People with back pain
have lower physical activity, which in turn leads to an weight gain and a deterioration in
physical performance. Among the drugs used for obesity, orlistat has been approved for
long-term use, and phentermine, the most commonly used drug, has been approved for short-term
use. However, phentermine can increase blood pressure and pulse rate. Meanwhile, several
studies have shown that orlistat, a pancreatic lipase inhibitor, lowers blood pressure and
pulse rate and diminish LDL-cholesterol. Lowering LDL-C could lead to improved vascular
endothelial function.
The investigators aimed to investigate the effect of orlistat and phentermine combination
therapy on weight loss and improvement of vascular function compared to phentermine
monotherapy in obese patients (BMI 27 kg/m2) with metabolic risk and back pain.
The investigators aimed to investigate the effect of orlistat and phentermine combination
therapy on weight loss and improvement of vascular function compared to phentermine
monotherapy in obese patients (BMI 27 kg/m2) with metabolic risk and back pain.
Randomized placebo-controlled clinical trials (12 weeks), Patients: Obese patients (BMI 27
kg/m2) with metabolic risk and back pain
The patients were divided into two groups: orlistat (120mg, three times a day), phentermine
(37.5 mg, once a day) combined Group (N = 57), placebo (placebo, three times a day) and
phentermine (37.5 mg, once a day) Group (N=57).
Randomly assigned to each group at 1: 1, and allocation codes are generated using SAS (Ver.
9.2). The investigators provide orlistat and phentermine or placebo and phentermine. The
investigators check physical measurement, blood test, questionnaire, blood pressure and
pulse, body composition, FMD, heart rate variability test, in the first visit. The
investigators check for changes in body weight, compliance, and side effects after 4 weeks
and 8 weeks, respectively. After 12 weeks, the investigators re-check physical measurement,
blood test, questionnaire, blood pressure and pulse, body composition, FMD, heart rate
variability test.
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