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Completed

NCT Number: NCT01157936

Hyperuricemia on Hypertension and Metabolic Syndrome

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.

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Key information

Conditions

Systolic and Diastolic Blood Pressure Levels Cardiovascular Diseases Glucose Metabolism Disorders Heart Murmurs Hepatic Enzymes Hyperinsulinism Hypertension Hyperuricemia Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome Parameters Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Systolic Murmurs Uric Acid Levels Vascular Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Insituto Nacional de Cardiología Ignacio Chávez

México, State of Mexico, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allopurinol

Drug

daily dosage

Other names: xanthine oxidase inhibitor

Placebo

Other

daily dosage

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2010
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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