Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 17046, South Korea
NCT Number: NCT03675191
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Yongin-si, Gyeonggi-do, 17046, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal
Other names: Lipidown Cap
Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
Other names: Phentermine Pill 37.5mg
Time frame: 12weeks
Body mass index in kg/m2.
Time frame: 12weeks
Vascular function will be assessed using the flow mediated dilatation (%).
Time frame: 12weeks
Assessments using a Visual Analog Score for pain Visual Analog Scale (total score 10, minimum;0, no pain, maximum; 10, severe pain)
Gangnam Severance Hospital
Other
The Effects of Orlistat/Phentermine Versus Placebo/Phentermine Treatment on Weight Loss and Vascular Function of Overweight Patients With Back Pain
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