Hyperuricemia on Hypertension and Metabolic Syndrome

NCT ID: NCT01157936

Last Updated: 2014-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Allopurinol treatment

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

daily dosage

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

daily dosage

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allopurinol

daily dosage

Intervention Type DRUG

placebo

daily dosage

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

xanthine oxidase inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Council of Science and Technology, Mexico

OTHER

Sponsor Role collaborator

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Magdalena Madero

Chief Nephrology Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Magdalena Madero, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiología Ignacio Chávez

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Insituto Nacional de Cardiología Ignacio Chávez

México, State of Mexico, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.

Reference Type DERIVED
PMID: 21849262 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALOPURINOL

Identifier Type: OTHER

Identifier Source: secondary_id

HYPERURICEMIA 2010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gout Dose Response Study
NCT00955981 COMPLETED PHASE2