The Effect of Allopurinol on Insulin Resistance and Blood Pressure

Hospital Mateo Orfila

Status and phase: Completed; Phase 2

Conditions: Metabolic Syndrome

Treatments: Drug: Allopurinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00639756

IbSalut-M-001

Details and patient eligibility

About

Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.

Full description

60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males, age 40 -65 yrs

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Other group

Description:

Placebo

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

Allopurinol given for 2 weeks with diet

Treatment:

Drug: Allopurinol