Official Title: “Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Allopurinol
  • Allopurinol 300 mg
• Drug: Placebo
  • Placebo given for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Placebo
• Active Comparator: 2
  • Allopurinol given for 2 weeks with diet

Primary Measures

• Insulin resistance (HOMA index)
  • Time Frame: 2 weeks
    Safety Issue?: No
• blood pressure
  • Time Frame: 2 weeks
    Safety Issue?: No
• Triglycerides, HDL cholesterol
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• Adiponectin
  • Time Frame: 2 weeks
    Safety Issue?: No
• Leptin
  • Time Frame: 2 weeks
    Safety Issue?: No
• CRP level
  • Time Frame: 2 weeks
    Safety Issue?: No
• Weight gain
  • Time Frame: 2 weeks
    Safety Issue?: No

Inclusion Criteria:

• Males, age 40 -65 yrs

Exclusion Criteria:

• None

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Hospital Mateo Orfila

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00639756

Study ID Number: IbSalut-M-001

ClinicalTrials.gov Identifier: NCT00639756

Health Authority: Spain: Ethics Committee