Effect of Allopurinol Treatment on Insulin Resistance

Not Applicable

• Conditions: Hyperuricemia; Prediabetes; Insulin Resistance
• Interventions: Drug: allopurinol 300 mg./day; Other: No intervention; Drug: Normouricemic

• Registration Number: NCT02008968
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-07
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11
• Primary Completion: 2014-07
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Age ≥ 30
• Serum uric acid level ≥7mg/dL
• Glomerular filtration rate ≥60 ml/min

Exclusion Criteria

• presence of Diabetes Mellitus
• history of gout
• history of allopurinol use
• body mass index ≥35 kg/m2
• proteinuria ≥ 1gr/ day
• presence of autoimmune disease
• rheumatology associated disease
• presence of hypothyroidism or hyperthyroidism
• presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uric acid ≥7 mg/dL	allopurinol 300 mg./day	This arm will receive allopurinol treatment. 50 subjects will be recruited.
Uric acid ≥6 and <7	No intervention	This arm will not receive allopurinol. 50 subjects will be recruited.
Normouricemic	Normouricemic	This arm is healthy controls. 30 subjects will be recruited.

Primary Outcome Measures

Name	Time	Method
Change in insulin resistance (HOMA-IR)	baseline and 3 months

Trial Locations

Locations (1)

Istanbul Medeniyet University Goztepe Training and Research Hospital; 🇹🇷 Istanbul, Marmara, Turkey