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Hyperuricemia on Hypertension and Metabolic Syndrome

Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01157936
Enrollment
40
Registered
2010-07-08
Start date
2010-07-31
Completion date
2011-08-31
Last updated
2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hypertension, hyperuricemia, metabolic syndrome

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.

Interventions

DRUGAllopurinol

daily dosage

OTHERplacebo

daily dosage

Sponsors

National Council of Science and Technology, Mexico
CollaboratorOTHER
Instituto Nacional de Cardiologia Ignacio Chavez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of hyperuricemia treatment on systemic blood pressure14 weeksparticipants 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

MeasureTime frameDescription
Effect of hyperuricemia treatment on metabolic syndrome parameters14 weeksbaseline and final laboratory samples during pre and post crossover periods will include metabolic syndrome measurements (triglycerides, cholesterol, glucose and abdominal perimeter).

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026