Hyperuricemia on Hypertension and Metabolic Syndrome
Systolic and Diastolic Blood Pressure Levels
Uric Acid Levels
Metabolic Syndrome Parameters
|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|
- 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.
- 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).
|Study Start Date:||July 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Allopurinol treatment||
Other Name: xanthine oxidase inhibitor
|Placebo Comparator: Placebo||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157936
|Insituto Nacional de Cardiología Ignacio Chávez|
|Mexico, Mexico, 14080|
|Principal Investigator:||Magdalena Madero, MD||Instituto Nacional de Cardiología Ignacio Chávez|