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Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT

ConditionsGoutObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXueMei Guo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meeting the 2015 ACR/EULAR classification criteria for gout.

Age 18-70 years.

BMI ≥28 kg/m².

Serum uric acid ≥480 μmol/L.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orlistat 120 mg

    Drug

    Oral capsule, taken after meals, 120 mg three times daily (tid) for 24 weeks.

  • Allopurinol 100 up to 600mg/day

    Drug

    Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.

  • Febuxostat 40mg Tab

    Drug

    Standard urate-lowering therapy (e.g., allopurinol or febuxostat), with doses adjusted based on serum uric acid levels and liver/kidney function.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: the experimental GroupExperimental treatment 3 interventions
Group B: The control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

The rate of patients achieving target serum uric acid levels

The rate of patients achieving serum uric acid \< 360 μmol/L

Time frame
24 weeks

Secondary outcomes

1

changes in body weight

The proportion of patients with a weight loss of ≥5%,the unit of weight is Kilogram(Kg).

Time frame
24 weeks
2

inflammatory markers

changes in the frequency of gout attacks, changes in inflammatory markers (CRP, IL-1β, etc.).The unit of CRP is mg/L,the unit of ESR is mm/h,the unit of IL- 1β is pg/mL.

Time frame
24 weeks
3

the expression of AMPK-HIF1-inflammasome

changes in the expression of key molecules in the AMPK-HIF1-inflammasome axis.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

XueMei Guo

Lead sponsor

General Hospital of Shenyang Military Region

Sponsor institution

Shengjing Hospital

Collaborator

The People's Hospital of Liaoning Province

Collaborator

Source ClinicalTrials.gov

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