HyperuricemiaNCT02008968
Effect of Allopurinol Treatment on Insulin Resistance
A study testing allopurinol 300 mg./day and Normouricemic in people with Hyperuricemia and Prediabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Prediabetes, Insulin Resistance
- What is being tested?
- allopurinol 300 mg./day and Normouricemic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to Aug 2014
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 30
- Serum uric acid level ≥7mg/dL
- Glomerular filtration rate ≥60 ml/min
Who cannot join
- presence of Diabetes Mellitus
- history of gout
- history of allopurinol use
- body mass index ≥35 kg/m2
- proteinuria ≥ 1gr/ day
- presence of autoimmune disease
Show all 9Show fewer
- rheumatology associated disease
- presence of hypothyroidism or hyperthyroidism
- presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, Marmara, 34353
Mehmet Kanbay, Associate Professor, +902165709294, drkanbay@yahoo.com
Mehmet Kanbay
About this study
Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.
- Conditions
- Hyperuricemia, Prediabetes, Insulin Resistance
- Being tested
- allopurinol 300 mg./day, No intervention, Normouricemic
- Medical subject headings
- Hyperuricemia, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allopurinol 300 mg./dayDrug
No interventionOther
NormouricemicDrug
| Study group | Role | What they receive |
|---|---|---|
| Uric acid ≥7 mg/dL | Active comparator | This arm will receive allopurinol treatment. 50 subjects will be recruited. Receives: Drug: allopurinol 300 mg./day |
| Uric acid ≥6 and <7 | Active comparator | This arm will not receive allopurinol. 50 subjects will be recruited. Receives: Other: No intervention |
| Normouricemic | Placebo comparator | This arm is healthy controls. 30 subjects will be recruited. Receives: Drug: Normouricemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance (HOMA-IR)
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2014 (estimated)
- Study completionAug 2014 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kanbay, Istanbul Medeniyet University
- Investigators
- Ali Bakan, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008968
- Sponsor's protocol ID
- Allo2013
- Status last verified
- Dec 2013
- First submitted
- 7 Dec 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Allopurinol Treatment on Insulin Resistance
- ClinicalTrials.gov ID
- NCT02008968
- Acronym / sponsor ID
- Allo2013
- Conditions
- Hyperuricemia, Prediabetes, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 11 Dec 2013 (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.
Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uric acid ≥7 mg/dL | Active comparator | Drug: allopurinol 300 mg./dayThis arm will receive allopurinol treatment. 50 subjects will be recruited. |
| Uric acid ≥6 and <7 | Active comparator | Other: No interventionThis arm will not receive allopurinol. 50 subjects will be recruited. |
| Normouricemic | Placebo comparator | Drug: NormouricemicThis arm is healthy controls. 30 subjects will be recruited. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 30
- Serum uric acid level ≥7mg/dL
- Glomerular filtration rate ≥60 ml/min
Key exclusion criteria (9 listed)
- presence of Diabetes Mellitus
- history of gout
- history of allopurinol use
- body mass index ≥35 kg/m2
- proteinuria ≥ 1gr/ day
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 |
|---|---|---|
| allopurinol 300 mg./day | Drug | Uric acid ≥7 mg/dL |
| No intervention | Other | Uric acid ≥6 and <7 |
| Normouricemic | Drug | Normouricemic |
Primary outcome
Change in insulin resistance (HOMA-IR)
Time frame: baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Ali Bakan principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allopurinol 300 mg./day and Normouricemic in people with Hyperuricemia and Prediabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 11 Dec 2013. 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 Turkey (Türkiye). 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.
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 Mehmet Kanbay, Associate Professor (+902165709294, drkanbay@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin resistance (HOMA-IR) (time frame: baseline and 3 months). 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 11 Dec 2013.