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The Effect of Allopurinol on Insulin Resistance and Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639756
First Posted: March 20, 2008
Last Update Posted: October 13, 2008
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.
Information provided by:
Hospital Mateo Orfila
  Purpose
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
1
Placebo
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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Males, age 40 -65 yrs

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00639756


Locations
Spain
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PEREZ-POZO, SANTOS E. LOPEZ-LILLO, JULIAN. JOHNSON, RICHARD, MATEO ORFILA HOSPITAL, University of Florida
ClinicalTrials.gov Identifier: NCT00639756     History of Changes
Other Study ID Numbers: IbSalut-M-001
First Submitted: March 10, 2008
First Posted: March 20, 2008
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by Hospital Mateo Orfila:
Uric acid
Fructose
Hypertension
Insulin
Glucose
HOMA

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs