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
Verified date | October 2019 |
Source | Gangnam Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | August 12, 2019 |
Est. primary completion date | July 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - After a screening test, the characteristics of the trial were explained and then the patient voluntarily agreed to participate in the study and signed a consent form with IRB approval. - Adults over 20 years of age at the time of obtaining consent - A back pain score of 3 and a metabolic risk of a BMI greater than 27 kg / m2. - Metabolic risk includes the following, according to the American Endocrinology Society (AACE) guidelines. (Diabetic stage, metabolic syndrome, type 2 diabetes, dyslipidemia, hypertension, cardiovascular disease, nonalcoholic fatty liver, polycystic ovary syndrome, obstructive sleep apnea, osteoarthritis, gastroesophageal - In the case of a pregnant woman, pregnancy test is negative - Patients who can understand and speak Korean - Patients whose physicians approved to participate in the study - Patients who are able to complete the study without participating in other intervention studies (drug, diet, exercise intervention studies) during the study period. - Patients who agreed to contraception during the study Exclusion Criteria: 1. Persons who are contraindicated for Phentermine Sympathomized excitable amines sensitive patients or patients with specific qualities Progressive arteriosclerosis patients Patients with symptomatic cardiovascular disease When there is pulmonary hypertension or heart valve disease A patient with hyperthyroidism A patient with glaucoma Patients who are extremely anxious or excited mentally person who had history of drug abuse Patients taking other central nervous system stimulants or those 14 days after the administration of MAO inhibitors (MAOIs) 2. Persons who are contraindicated for Orlistat Patient with chronic malabsorption syndrome or patient who stops secretion of juice Patients with hypersensitivity to this or this component 3. Uncontrolled hypertenstion (SBP>180mmHg or DBP >120mmHg) 4. Under taking anti-diabetics or fasting blood glucose >=200mg/dl 5. If your weight has decreased by more than 5 kg in the last 3 months 6. (AST or ALT> 3 times the normal value) or kidney disease (serum creatinine> 2.0 mg / dL) 7. Patients taking other clinical trial drugs 8. Patients taking other appetite suppressants within the last 30 days 9. Acute infectious diseases such as pneumonia, acute enteritis, and acute urinary tract infections 10. If you are participating in other clinical trials 11. Those who are deemed unsuitable for participating in this study by the researcher |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yongin Severance Hospital | Yongin-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass index changes | Body mass index in kg/m2. | 12weeks | |
Primary | Vascular function changes | Vascular function will be assessed using the flow mediated dilatation (%). | 12weeks | |
Secondary | 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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