None listed
Conditions
Interventions
Drug : Randomized placebo-controlled clinical trials (12 weeks)
-orlistat (120mg, three times a day, within 1hour after meal) + phentermin (37.5mg, once a day, within 1hour after meal)
-placebo (120mg
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary purpose of this study was to evaluate the effect of orlistat and phentermine combination therapy on weight loss in patients with a BMI greater than 27kg/m2 with high metabolic risk.;The primary purpose of this study was to evaluate the effect of orlistat and phentermine combination therapy on improvement of vascular function in patients with a BMI greater than 27kg/m2 with high metabolic risk. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of combination of orlistat and phentermine on lipid profile changes and inflammatory markers compared to phentermine monotherapy;effect of combination of orlistat and phentermine on heart rate variability compared to phentermine monotherapy;effect of combination of orlistat and phentermine on the improvement of lower back pain compared to phentermine monotherapy | — |
Countries
Korea, Republic of
Contacts
Public ContactYu-Jin Kwon
Yonsei University Health System, Yongin Severance Hospital
Outcome results
None listed