MedPath

The Effect of Allopurinol on Insulin Resistance and Blood Pressure

Phase 2
Completed
Conditions
Metabolic Syndrome
Interventions
Drug: Placebo
Registration Number
NCT00639756
Lead Sponsor
Hospital Mateo Orfila
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
60
Inclusion Criteria
  • Males, age 40 -65 yrs
Exclusion Criteria
  • None

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1PlaceboPlacebo
2AllopurinolAllopurinol given for 2 weeks with diet
Primary Outcome Measures
NameTimeMethod
Insulin resistance (HOMA index)2 weeks
Blood pressure2 weeks
Triglycerides, HDL cholesterol2 weeks
Secondary Outcome Measures
NameTimeMethod
Adiponectin2 weeks
Leptin2 weeks
CRP level2 weeks
Weight gain2 weeks

Trial Locations

Locations (1)

Renal Unit, Mateo Orfila Hospital

🇪🇸

Menorca, Balearic Islands, Spain

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