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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orlistat | Experimental | Orlistat 120Mg Cap (120mg, three times a day, within 1hour after meal) combined with phentermine pill (37.5mg, once a day, within 1hour after meal) |
|
| placebo | Placebo Comparator | placebo (120mg, three times a day, within 1hour after meal) combined with phentermine pill (37.5mg, once a day, within 1hour after meal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orlistat 120Mg Cap | Drug | Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index changes | Body mass index in kg/m2. | 12weeks |
| Vascular function changes | Vascular function will be assessed using the flow mediated dilatation (%). | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Back pain | Assessments using a Visual Analog Score for pain Visual Analog Scale (total score 10, minimum;0, no pain, maximum; 10, severe pain) | 12weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Yongin-si | Gyeonggi-do | 17046 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33688228 | Derived | Kwon YJ, Lee H, Nam CM, Chang HJ, Yoon YR, Lee HS, Lee JW. Effects of Orlistat/Phentermine versus Phentermine on Vascular Endothelial Cell Function in Obese and Overweight Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial. Diabetes Metab Syndr Obes. 2021 Mar 2;14:941-950. doi: 10.2147/DMSO.S300342. eCollection 2021. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| D002214 | Capsules |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Randomized placebo-controlled clinical trials (12 weeks)
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The placebo pill is given to participants who are randomly assigned to the control group.
Double-blinded
| Phentermine Pill | Drug | Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal |
|
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000662 |
| Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |