Back to resultsEffect of Allopurinol Treatment on Insulin Resistance
Primary Purpose
Hyperuricemia, Prediabetes, Insulin Resistance
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
allopurinol 300 mg./day
No intervention
Normouricemic
Sponsored by
About this trial
This is an interventional prevention trial for Hyperuricemia
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 30
- Serum uric acid level ≥7mg/dL
- Glomerular filtration rate ≥60 ml/min
Exclusion Criteria:
- 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)
Sites / Locations
- Istanbul Medeniyet University Goztepe Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Uric acid ≥7 mg/dL
Uric acid ≥6 and <7
Normouricemic
Arm Description
This arm will receive allopurinol treatment. 50 subjects will be recruited.
This arm will not receive allopurinol. 50 subjects will be recruited.
This arm is healthy controls. 30 subjects will be recruited.
Outcomes
Primary Outcome Measures
Change in insulin resistance (HOMA-IR)
Secondary Outcome Measures
Full Information
NCT ID
NCT02008968
First Posted
December 7, 2013
Last Updated
December 10, 2013
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT02008968
Brief Title
Effect of Allopurinol Treatment on Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Prediabetes, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Uric acid ≥7 mg/dL
Arm Type
Active Comparator
Arm Description
This arm will receive allopurinol treatment. 50 subjects will be recruited.
Arm Title
Uric acid ≥6 and <7
Arm Type
Active Comparator
Arm Description
This arm will not receive allopurinol. 50 subjects will be recruited.
Arm Title
Normouricemic
Arm Type
Placebo Comparator
Arm Description
This arm is healthy controls. 30 subjects will be recruited.
Intervention Type
Drug
Intervention Name(s)
allopurinol 300 mg./day
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Type
Drug
Intervention Name(s)
Normouricemic
Primary Outcome Measure Information:
Title
Change in insulin resistance (HOMA-IR)
Time Frame
baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 30
Serum uric acid level ≥7mg/dL
Glomerular filtration rate ≥60 ml/min
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Kanbay, Associate Professor
Phone
+902165709294
Email
drkanbay@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Bakan
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medeniyet University Goztepe Training and Research Hospital
City
Istanbul
State/Province
Marmara
ZIP/Postal Code
34353
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Kanbay, Associate Professor
Phone
+902165709294
Email
drkanbay@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mehmet Kanbay
12. IPD Sharing Statement
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Effect of Allopurinol Treatment on Insulin Resistance
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