Clinical trial NCT05496075: Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
Official title: Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing Uric Acid in Overweight/Obese Patients With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uric Acid
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.-

Primary outcomes:
measure: level of uric acid
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's hospital
state: Shanghai
Study officials:
References: