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Hyperuricemia on Hypertension and Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01157936
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : July 24, 2014
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary:
The purpose of this study is to evaluate the influence of hyperuricemia treatment compared with placebo on participants with high risk of hypertension and metabolic syndrome.

Condition or disease Intervention/treatment Phase
Systolic and Diastolic Blood Pressure Levels Uric Acid Levels Metabolic Syndrome Parameters Hepatic Enzymes Drug: Allopurinol Other: placebo Phase 2

Detailed Description:

Elevated consumption of high fructose corn syrup has lead to an increase of 30% of fructose intake since the last 20 years. Important data supporting this fact can be reflected on incidence and prevalence of Metabolic syndrome and hyperuricemia.

A peculiar effect of fructose intake demonstrated in animal models is the development of elevated uric acid levels; also some studies have found a clear association between hyperuricemia as an important risk factor for hypertension, diabetes mellitus, chronic kidney disease and metabolic syndrome.

Taking into account the existing evidence, our clinical research team presents this protocol as a way to evaluate the effect of uric acid treatment and its relation with Fructose consumption, metabolic syndrome parameters, hyperuricemia and risk of hypertension.

Confirming evidence with clinical basis may be the initial strategy to create primary prevention programs to control this health problems affecting Mexican Population.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome
Study Start Date : July 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : August 2011


Arm Intervention/treatment
Active Comparator: Allopurinol treatment Drug: Allopurinol
daily dosage
Other Name: xanthine oxidase inhibitor
Placebo Comparator: Placebo Other: placebo
daily dosage



Primary Outcome Measures :
  1. Effect of hyperuricemia treatment on systemic blood pressure [ Time Frame: 14 weeks ]
    participants will be randomized to a 4 week placebo versus alopurinol treatment followed by a wash out period. After crossover them, they will receive the complementary pharmacological intervention for another 4 weeks.


Secondary Outcome Measures :
  1. Effect of hyperuricemia treatment on metabolic syndrome parameters [ Time Frame: 14 weeks ]
    baseline and final laboratory samples during pre and post crossover periods will include metabolic syndrome measurements (triglycerides, cholesterol, glucose and abdominal perimeter).



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg
  • no pharmacological treatment for blood pressure control

Exclusion Criteria:

  • hypertension (more than 140/90mmHg)
  • Diabetes Mellitus type 1 or 2
  • Chronic kidney disease (MDRD less than 60)
  • Hepatic Disease
  • Malignancy
  • Pregnancy
  • patient receiving any medication

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): NCT01157936


Locations
Mexico
Insituto Nacional de Cardiología Ignacio Chávez
Mexico, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Magdalena Madero, MD Instituto Nacional de Cardiología Ignacio Chávez

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Magdalena Madero, Chief Nephrology Division, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT01157936     History of Changes
Other Study ID Numbers: HYPERURICEMIA 2010
ALOPURINOL ( Other Identifier: ALUPORINOL )
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
hypertension
hyperuricemia
metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Hypertension
Metabolic Syndrome X
Hyperuricemia
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
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