NCT05496075已完成4 期
Observational Study on Clinical Efficacy and Safety of Orlistat in Reducing Uric Acid in Overweight/Obese Patients With Hyperuricemia
Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年8月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- level of uric acid
研究概览
简要总结
To clarify the uric acid-lowering efficacy of orlistat in overweight/obese patients with hyperuricemia, and to evaluate the safety of orlistat treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(Items 1, 2, and 4 meet at the same time, and items 3 and 5 meet one of them)
- •Obtain the informed consent of the subjects before any trial-related activities (including activities carried out to assess the eligibility of subjects);
- •Men or women over the age of 18 at the time of screening;
- •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.
- •The weight meets the following requirements (a or b): a) BMI ≥ 25.0 kg/m2; b) waist circumference, female ≥ 85 cm, male ≥ 90 cm.
- •Suffering from hyperuricemia and/or gout.-
排除标准
- •Use of drugs that may affect uric acid within 1 month before enrollment, including; benzbromarone, allopurinol, febuxostat, etc.;
- •Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal;
- •Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.;
- •Diabetic patients with poor blood sugar control: HbA1c>7%;
- •Chronic kidney disease or severe renal impairment, according to eGFR grading <45mL/min/1.73m2;
- •The life expectancy does not exceed 5 years;
- •Female subjects who are pregnant or plan to become pregnant within the next 24 weeks;
- •Those who are expected to be unable to complete the intervention follow-up in other circumstances;
- •If other drugs are used in combination, the drug dose should be kept stable for three months before enrollment;
- •Participated in other clinical trials within the past 4 weeks;
- •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.;
- •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.;
- •Inability to complete the exercise and for other reasons, the researcher believes that it is not suitable to participate in this researcher.-
研究组 & 干预措施
Orlistat group
Experimental
Orlistat was administered orally on the basis of lifestyle guidance.
干预措施: Orlistat (Drug)
control group
Placebo Comparator
Orlistat placebo was administered orally on the basis of lifestyle guidance.
干预措施: Orlistat placebo (Drug)
结局指标
主要结局
level of uric acid
时间窗: Month 3
Change from Baseline Uric acid at 3 months
次要结局
未报告次要终点
研究者
Zhang Manna
Deputy Chief Physician
Shanghai 10th People's Hospital
研究点 (1)
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