Hyperuricemia on Hypertension and Metabolic Syndrome

Study Overview
=================
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.

Official Title
-----------------
Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome

Conditions
-----------------
Systolic and Diastolic Blood Pressure Levels, Uric Acid Levels, Metabolic Syndrome Parameters, Hepatic Enzymes

Intervention / Treatment
-----------------
* Drug: Allopurinol
* Other: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol treatment<br> | Drug: Allopurinol<br>* daily dosage<br>* Other names: xanthine oxidase inhibitor;|
| Placebo Comparator: Placebo<br> | Other: placebo<br>* daily dosage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of hyperuricemia treatment on systemic blood pressure | 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. | 14 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, hyperuricemia, metabolic syndrome