Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT
NCT07326839 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-01-08
Summary
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.
Conditions
Interventions
- DRUG
-
Orlistat 120 mg
Oral capsule, taken after meals, 120 mg three times daily (tid) for 24 weeks.
- DRUG
-
Allopurinol 100 up to 600mg/day
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
- DRUG
-
Febuxostat 40mg Tab
Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.
Sponsors & Collaborators
-
Shengjing Hospital
collaborator OTHER -
The People's Hospital of Liaoning Province
collaborator OTHER -
XueMei Guo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-10
- Primary Completion
- 2027-11-09
- Completion
- 2027-11-09
Countries
- China
Study Locations
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