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The Effect of Allopurinol on Insulin Resistance and Blood Pressure

Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00639756
Enrollment
60
Registered
2008-03-20
Start date
2008-06-30
Completion date
2008-10-31
Last updated
2008-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Uric acid, Fructose, Hypertension, Insulin, Glucose, HOMA

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.

Interventions

DRUGAllopurinol

Allopurinol 300 mg

DRUGPlacebo

Placebo given for 2 weeks

Sponsors

Hospital Mateo Orfila
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Males, age 40 -65 yrs

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Insulin resistance (HOMA index)2 weeks
Blood pressure2 weeks
Triglycerides, HDL cholesterol2 weeks

Secondary

MeasureTime frame
Adiponectin2 weeks
Weight gain2 weeks
Leptin2 weeks
CRP level2 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026