Hyperuricemia on Hypertension and Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT01157936
First received: July 7, 2010
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cardiologia Ignacio Chavez:

Primary Outcome Measures:
  • Effect of hyperuricemia treatment on systemic blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Effect of hyperuricemia treatment on metabolic syndrome parameters [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
    baseline and final laboratory samples during pre and post crossover periods will include metabolic syndrome measurements (triglycerides, cholesterol, glucose and abdominal perimeter).


Estimated Enrollment: 40
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allopurinol treatment Drug: Allopurinol
daily dosage
Other Name: xanthine oxidase inhibitor
Placebo Comparator: Placebo Other: placebo
daily dosage

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Instituto Nacional de Cardiologia Ignacio Chavez

Additional 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
Study First Received: July 7, 2010
Last Updated: July 23, 2014
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 31, 2014