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Hyperuricemia on Hypertension and Metabolic Syndrome

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Allopurinol
placebo
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Systolic and Diastolic Blood Pressure Levels focused on measuring hypertension, hyperuricemia, metabolic syndrome

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Insituto Nacional de Cardiología Ignacio Chávez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allopurinol treatment

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 7, 2010
Last Updated
July 23, 2014
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01157936
Brief Title
Hyperuricemia on Hypertension and Metabolic Syndrome
Official Title
Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic and Diastolic Blood Pressure Levels, Uric Acid Levels, Metabolic Syndrome Parameters, Hepatic Enzymes
Keywords
hypertension, hyperuricemia, metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol treatment
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
xanthine oxidase inhibitor
Intervention Description
daily dosage
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
daily dosage
Primary Outcome Measure Information:
Title
Effect of hyperuricemia treatment on systemic blood pressure
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Effect of hyperuricemia treatment on metabolic syndrome parameters
Description
baseline and final laboratory samples during pre and post crossover periods will include metabolic syndrome measurements (triglycerides, cholesterol, glucose and abdominal perimeter).
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, MD
Organizational Affiliation
Instituto Nacional de Cardiología Ignacio Chávez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insituto Nacional de Cardiología Ignacio Chávez
City
Mexico
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
21849262
Citation
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.
Results Reference
derived

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Hyperuricemia on Hypertension and Metabolic Syndrome

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