Effect of Allopurinol Treatment on Insulin Resistance
1 other identifier
interventional
130
1 country
1
Brief 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. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 7, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedDecember 11, 2013
December 1, 2013
7 months
December 7, 2013
December 10, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in insulin resistance (HOMA-IR)
baseline and 3 months
Study Arms (3)
Uric acid ≥7 mg/dL
ACTIVE COMPARATORThis arm will receive allopurinol treatment. 50 subjects will be recruited.
Uric acid ≥6 and <7
ACTIVE COMPARATORThis arm will not receive allopurinol. 50 subjects will be recruited.
Normouricemic
PLACEBO COMPARATORThis arm is healthy controls. 30 subjects will be recruited.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 30
- Serum uric acid level ≥7mg/dL
- Glomerular filtration rate ≥60 ml/min
You may not qualify if:
- presence of Diabetes Mellitus
- history of gout
- history of allopurinol use
- body mass index ≥35 kg/m2
- proteinuria ≥ 1gr/ day
- presence of autoimmune disease
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, Marmara, 34353, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Bakan
Istanbul Medeniyet University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Doctor Mehmet Kanbay
Study Record Dates
First Submitted
December 7, 2013
First Posted
December 11, 2013
Study Start
December 1, 2013
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
December 11, 2013
Record last verified: 2013-12