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The Effect of Allopurinol on Insulin Resistance and Blood Pressure

This study has been completed.
Information provided by:
Hospital Mateo Orfila Identifier:
First received: March 10, 2008
Last updated: October 10, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Metabolic Syndrome Drug: Allopurinol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion

Resource links provided by NLM:

Further study details as provided by Hospital Mateo Orfila:

Primary Outcome Measures:
  • Insulin resistance (HOMA index) [ Time Frame: 2 weeks ]
  • Blood pressure [ Time Frame: 2 weeks ]
  • Triglycerides, HDL cholesterol [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Adiponectin [ Time Frame: 2 weeks ]
  • Leptin [ Time Frame: 2 weeks ]
  • CRP level [ Time Frame: 2 weeks ]
  • Weight gain [ Time Frame: 2 weeks ]

Estimated Enrollment: 60
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Drug: Placebo
Placebo given for 2 weeks
Active Comparator: 2
Allopurinol given for 2 weeks with diet
Drug: Allopurinol
Allopurinol 300 mg

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.

Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males, age 40 -65 yrs

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00639756

Renal Unit, Mateo Orfila Hospital
Menorca, Balearic Islands, Spain, 07703
Sponsors and Collaborators
Hospital Mateo Orfila
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PEREZ-POZO, SANTOS E. LOPEZ-LILLO, JULIAN. JOHNSON, RICHARD, MATEO ORFILA HOSPITAL, University of Florida Identifier: NCT00639756     History of Changes
Other Study ID Numbers: IbSalut-M-001
Study First Received: March 10, 2008
Last Updated: October 10, 2008

Keywords provided by Hospital Mateo Orfila:
Uric acid

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs processed this record on August 23, 2017