HyperuricemiaNCT03473444
Prevalence of Hyperuricemia in Pakistan
An observational study of Hyperuricemia, run by OBS Pakistan at 1 site in Pakistan.
Trial summary
The prevalence of hyperuricemia has rarely been investigated in developing countries Hyperuricemia, or raised serum uric acid (SUA), is the condition closely associated with gout due to the deposition of monosodium urate crystals in peripheral joints and soft tissues. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2018to 15 Apr 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Informed consent was obtained from all patients and their attendant coming to clinics. Those who agreed to be part of this study were asked a questionnaire about co-morbidity and symptoms. Uric acid levels were assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.
Who may be able to join
- Informed Consent given
Who cannot join
- No Informed consent provided
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dr. Abid Naeem
Mirpur, Azad Kashmir
Abid Naeem, MBBS, MCPS, 3018504909, abidnaeem56@yahoo.com
About this study
The prevalence of hyperuricemia has rarely been investigated in developing countries Hyperuricemia, or raised serum uric acid (SUA), is the condition closely associated with gout due to the deposition of monosodium urate crystals in peripheral joints and soft tissues. Hyperuricemia is associated with an increased risk for incident hypertension, independent of traditional hypertension risk factors. This risk appears more pronounced in younger individuals and women. Cross-sectional studies show an association of hyperuricemia with the presence of CKD. Insulin resistance plays a potentially key role in the causal relationship between metabolic syndrome, type 2 Diabetes and hyperuricemia. Furthermore, it is likely that hyperuricemia and insulin resistance share a bidirectional causal effect. The rationale of this study is to determine prevalence of hyperuricemia in Pakistan.
Read the detailed description
Informed consent will be obtained from all patients and their attendant coming to clinics. Those who will agree to be part of this study were asked a questionnaire about co-morbidity and symptoms.
Uric acid levels will be assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.
- Conditions
- Hyperuricemia
- Keywords
- uric acid, prevalence, pakistan
- Medical subject headings
- Hyperuricemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hyperuricemia
To find out the frequency uric acid levels in Pakistani general population
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Apr 2018 (estimated)
- Study completion15 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OBS Pakistan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473444
- Sponsor's protocol ID
- ZeroGout-OBS-002
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hyperuricemia in Pakistan
- ClinicalTrials.gov ID
- NCT03473444
- Acronym / sponsor ID
- ZeroGout-OBS-002
- Conditions
- Hyperuricemia
- Keywords
- uric acid, prevalence, pakistan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- OBS PakistanIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 15 Apr 2018 (estimated)
- First posted
- 22 Mar 2018 (actual)
- 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 prevalence of hyperuricemia has rarely been investigated in developing countries Hyperuricemia, or raised serum uric acid (SUA), is the condition closely associated with gout due to the deposition of monosodium urate crystals in peripheral joints and soft tissues. Hyperuricemia is associated with an increased risk for incident hypertension, independent of traditional hypertension risk factors. This risk appears more pronounced in younger individuals and women. Cross-sectional studies show an association of hyperuricemia with the presence of CKD. Insulin resistance plays a potentially key role in the causal relationship between metabolic syndrome, type 2 Diabetes and hyperuricemia. Furthermore, it is likely that hyperuricemia and insulin resistance share a bidirectional causal effect. The rationale of this study is to determine prevalence of hyperuricemia in Pakistan.
Detailed description
Informed consent will be obtained from all patients and their attendant coming to clinics. Those who will agree to be part of this study were asked a questionnaire about co-morbidity and symptoms.
Uric acid levels will be assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Informed consent was obtained from all patients and their attendant coming to clinics. Those who agreed to be part of this study were asked a questionnaire about co-morbidity and symptoms. Uric acid levels were assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.
Key inclusion criteria (1 listed)
- Informed Consent given
Key exclusion criteria (1 listed)
- No Informed consent provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Hyperuricemia
Time frame: 4 weeks
To find out the frequency uric acid levels in Pakistani general population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia, run by OBS Pakistan at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faizan Shaukat (+923328814816, faizan.shaukat@obs.com.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hyperuricemia (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.