Hyperuricemia on Hypertension and Metabolic Syndrome

Phase 2

Completed

• Conditions: Systolic and Diastolic Blood Pressure Levels; Uric Acid Levels; Metabolic Syndrome Parameters; Hepatic Enzymes
• Interventions: Drug: Allopurinol; Other: placebo

• Registration Number: NCT01157936
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2011-02
• Study Completion: 2011-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Allopurinol treatment	Allopurinol	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Effect of hyperuricemia treatment on systemic blood pressure	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

Name	Time	Method
Effect of hyperuricemia treatment on metabolic syndrome parameters	14 weeks	baseline and final laboratory samples during pre and post crossover periods will include metabolic syndrome measurements (triglycerides, cholesterol, glucose and abdominal perimeter).

Trial Locations

Locations (1)

Insituto Nacional de Cardiología Ignacio Chávez; 🇲🇽 Mexico, Mexico