Optimization of Blood Uric Acid Control in Obese Gout Patients by Orlistat-Mediated Metabolic Remodeling and Intensive Weight Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The rate of patients achieving target serum uric acid levels
研究概览
简要总结
A total of 120 obese gout patients were included in a 24-week double-blind randomized controlled design. The intervention group received orlistat 120 mg tid + UTL + individualized diet-exercise-behavioral reinforcement weight loss program, while the control group received a placebo + UTL + standard recommendations. The primary endpoint was the rate of achieving serum uric acid levels <360 μmol/L at 24 weeks; secondary endpoints included the proportion of weight loss ≥5%, frequency of gout attacks, and inflammatory indicators such as CRP and IL-1β; the activity of AMPK in PBMCs and the expression of HIF1α and NLRP3 inflammasome-related proteins were also assessed.
详细描述
This study employs a double-blind, randomized, controlled trial design. A total of 120 obese gout patients were included and randomly divided into two groups: the intervention group (60 cases): Orlistat (120 mg tid) + UTL + personalized dietary guidance, exercise prescription, and behavioral intervention for a duration of 24 weeks. The control group (60 cases): placebo + UTL + standard weight control recommendations, with the same intervention duration. Both groups received standard uric acid-lowering therapy (such as allopurinol or febuxostat) according to guidelines, with dosages adjusted based on blood uric acid levels and liver and kidney function to maintain stability.
Study Flow and Assessment Indicators Baseline Assessment: demographic data, medical history collection; physical examination (weight, BMI, waist circumference, etc.); laboratory tests (blood routine, urine routine, sedimentation rate, CRP, blood glucose, blood lipids, blood uric acid, liver and kidney function, etc.); collection of peripheral blood mononuclear cells (PBMCs) for mechanistic studies.
Follow-up Assessments (weeks 4, 12, 24): Clinical Indicators: changes in weight, liver and kidney function, blood lipid levels, blood uric acid levels, frequency of gout attacks.
Safety Indicators: recording of adverse events. Mechanistic Study Indicators: detection of AMPK activity in PBMCs, expression levels of HIF1α, NLRP3, ASC, caspase-1, IL-1β, and metabolomics analysis.
Statistics : SPSS 23.0; t-test/Mann-Whitney U for continuous variables, chi-square for categorical data.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the 2015 ACR/EULAR classification criteria for gout.
- •Age 18-70 years.
- •BMI ≥28 kg/m².
- •Serum uric acid ≥480 μmol/L.
- •Willing and able to comply with the study protocol.
排除标准
- •Contraindications to orlistat or other gout medications.
- •Severe hepatic or renal dysfunction.
- •History of severe allergy or adverse reactions to study drugs.
- •Pregnant or lactating women.
- •Malignancy.
- •Secondary gout.
- •Poor compliance or inability to cooperate.
- •Participation in other clinical trials within the last 3 months.
研究组 & 干预措施
the experimental Group
The experimental Group received orlistat 120mg tid+ standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).
干预措施: Orlistat 120 mg (Drug)
the experimental Group
The experimental Group received orlistat 120mg tid+ standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).
干预措施: Allopurinol 100 up to 600mg/day (Drug)
the experimental Group
The experimental Group received orlistat 120mg tid+ standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).
干预措施: Febuxostat 40mg Tab (Drug)
The control group
The control group received placebo matching orlistat (tid) + standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).
干预措施: Allopurinol 100 up to 600mg/day (Drug)
The control group
The control group received placebo matching orlistat (tid) + standard ULT (e.g., febuxostat 40mg qd) + basic lifestyle advice (low-purine diet and exercise guidance).
干预措施: Febuxostat 40mg Tab (Drug)
结局指标
主要结局
The rate of patients achieving target serum uric acid levels
时间窗: 24 weeks
The rate of patients achieving serum uric acid \< 360 μmol/L
次要结局
- changes in body weight(24 weeks)
- inflammatory markers(24 weeks)
- the expression of AMPK-HIF1-inflammasome(24 weeks)
研究者
XueMei Guo
General Hospital of Shenyang Military Region
General Hospital of Shenyang Military Region