The Effect of Allopurinol on Insulin Resistance and Blood Pressure

This study has been completed.
Sponsor:
Information provided by:
Hospital Mateo Orfila
ClinicalTrials.gov Identifier:
NCT00639756
First received: March 10, 2008
Last updated: October 10, 2008
Last verified: October 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Triglycerides, HDL cholesterol [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adiponectin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Leptin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • CRP level [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Weight gain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males, age 40 -65 yrs

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00639756

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

No publications provided by Hospital Mateo Orfila

Additional 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
Study First Received: March 10, 2008
Last Updated: October 10, 2008
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 29, 2014