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The Effect of Allopurinol on Insulin Resistance and Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639756
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : October 13, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Allopurinol Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Drug: Placebo
Placebo given for 2 weeks

Active Comparator: 2
Allopurinol given for 2 weeks with diet
Drug: Allopurinol
Allopurinol 300 mg

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

Secondary Outcome Measures :
  1. Adiponectin [ Time Frame: 2 weeks ]
  2. Leptin [ Time Frame: 2 weeks ]
  3. CRP level [ Time Frame: 2 weeks ]
  4. Weight gain [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Males, age 40 -65 yrs

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639756

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Renal Unit, Mateo Orfila Hospital
Menorca, Balearic Islands, Spain, 07703
Sponsors and Collaborators
Hospital Mateo Orfila
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PEREZ-POZO, SANTOS E. LOPEZ-LILLO, JULIAN. JOHNSON, RICHARD, MATEO ORFILA HOSPITAL, University of Florida Identifier: NCT00639756    
Other Study ID Numbers: IbSalut-M-001
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008
Keywords provided by Hospital Mateo Orfila:
Uric acid
Additional relevant MeSH terms:
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Metabolic Syndrome
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