Uric Acid
Conditions
Brief summary
To clarify the uric acid-lowering efficacy of orlistat in overweight/obese patients with hyperuricemia, and to evaluate the safety of orlistat treatment
Interventions
DRUGOrlistat
Orlistat was administered orally on the basis of lifestyle guidance . Orlistat: Take 0.12g (1 capsule) with or within one hour after meals, 3 times a day. Medication time course: continuous administration for a total of 12 weeks.
DRUGOrlistat placebo
Lifestyle guidance: low-purine diet; orlistat placebo: take 1 capsule with or within one hour after a meal, 3 times a day. Medication time course: continuous administration for a total of 12 weeks.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
(Items 1, 2, and 4 meet at the same time, and items 3 and 5 meet one of them) 1. Obtain the informed consent of the subjects before any trial-related activities (including activities carried out to assess the eligibility of subjects); 2. Men or women over the age of 18 at the time of screening; 3. The diagnosis of hyperuricemia refers to the fasting of serum uric acid \> 420umol/L (7 mg/dl) twice on different days under a normal purine diet. 4. The weight meets the following requirements (a or b): a) BMI ≥ 25.0 kg/m2; b) waist circumference, female ≥ 85 cm, male ≥ 90 cm. 5. Suffering from hyperuricemia and/or gout.-
Exclusion criteria
1. Use of drugs that may affect uric acid within 1 month before enrollment, including; benzbromarone, allopurinol, febuxostat, etc.; 2. Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal; 3. Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.; 4. Diabetic patients with poor blood sugar control: HbA1c\>7%; 5. Chronic kidney disease or severe renal impairment, according to eGFR grading \<45mL/min/1.73m2; 6. The life expectancy does not exceed 5 years; 7. Female subjects who are pregnant or plan to become pregnant within the next 24 weeks; 8. Those who are expected to be unable to complete the intervention follow-up in other circumstances; 9. If other drugs are used in combination, the drug dose should be kept stable for three months before enrollment; 10. Participated in other clinical trials within the past 4 weeks; 11. Use of drugs that affect body weight within 3 months before screening, including: systemic steroids (intravenous, oral or intra-articular), tricyclic antidepressants, psychiatric drugs or sedatives (eg, imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salt), etc.; 12. Obesity caused by secondary diseases or drugs, including: elevated cortisol hormone (for example: Cushing's syndrome), obesity caused by pituitary and hypothalamus damage, obesity caused by reduction/discontinuation of weight loss drugs, etc.; 13. Inability to complete the exercise and for other reasons, the researcher believes that it is not suitable to participate in this researcher.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| level of uric acid | Month 3 | Change from Baseline Uric acid at 3 months |
Countries
China
Outcome results
None listed