Effect of Allopurinol Treatment on Insulin Resistance

Istanbul Medeniyet University

Status: Unknown

Conditions: Prediabetes; Hyperuricemia; Insulin Resistance

Treatments: Drug: allopurinol 300 mg./day; Drug: Normouricemic; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02008968

Allo2013

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups, including a placebo group

Uric acid ≥7 mg/dL

Active Comparator group

Description:

This arm will receive allopurinol treatment. 50 subjects will be recruited.

Treatment:

Drug: allopurinol 300 mg./day

Uric acid ≥6 and <7

Active Comparator group

Description:

This arm will not receive allopurinol. 50 subjects will be recruited.

Treatment:

Other: No intervention

Normouricemic

Placebo Comparator group

Description:

This arm is healthy controls. 30 subjects will be recruited.

Treatment:

Drug: Normouricemic