Systolic and Diastolic Blood Pressure LevelsPhase 2NCT01157936
Hyperuricemia on Hypertension and Metabolic Syndrome
A Phase 2 study testing Allopurinol in people with Systolic and Diastolic Blood Pressure Levels and Uric Acid Levels, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systolic and Diastolic Blood Pressure Levels, Uric Acid Levels, Metabolic Syndrome Parameters
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg
- no pharmacological treatment for blood pressure control
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Insituto Nacional de Cardiología Ignacio Chávez
México, State of Mexico, 14080
About this study
Official title: Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome
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.
Read the 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.
- Conditions
- Systolic and Diastolic Blood Pressure Levels, Uric Acid Levels, Metabolic Syndrome Parameters, Hepatic Enzymes
- Being tested
- Allopurinol, placebo
- Keywords
- hypertension, hyperuricemia, metabolic syndrome
- Medical subject headings
- Systolic Murmurs, Hypertension, Hyperuricemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called xanthine oxidase inhibitor
daily dosage
placeboOther
daily dosage
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol treatment | Active comparator | Not described Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Secondary outcomes (1)
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).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic and Diastolic Blood Pressure LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Magdalena Madero, MD, Principal investigator, Instituto Nacional de Cardiología Ignacio Chávez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157936
- Sponsor's protocol ID
- HYPERURICEMIA 2010
- Other IDs
- ALOPURINOL
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2010
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21849262
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01157936
- Acronym / sponsor ID
- HYPERURICEMIA 2010
- Conditions
- Systolic and Diastolic Blood Pressure Levels, Uric Acid Levels, Metabolic Syndrome Parameters, Hepatic Enzymes
- Keywords
- hypertension, hyperuricemia, metabolic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol treatment | Active comparator | Drug: Allopurinol |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg
- no pharmacological treatment for blood pressure control
Key exclusion criteria (7 listed)
- hypertension (more than 140/90mmHg)
- Diabetes Mellitus type 1 or 2
- Chronic kidney disease (MDRD less than 60)
- Hepatic Disease
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAlso: xanthine oxidase inhibitordaily dosage | Drug | Allopurinol treatment |
| placebodaily dosage | Other | Placebo |
Primary outcome
Effect of hyperuricemia treatment on systemic blood pressure
Time frame: 14 weeks
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.
1 secondary outcome
Effect of hyperuricemia treatment on metabolic syndrome parameters
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Derived from this study: PubMed 21849262Fravel 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Madero, MD principal investigator
Instituto Nacional de Cardiología Ignacio Chávez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol in people with Systolic and Diastolic Blood Pressure Levels and Uric Acid Levels, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of hyperuricemia treatment on systemic blood pressure (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.