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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02008968
Other study ID # Allo2013
Secondary ID
Status Recruiting
Phase N/A
First received December 7, 2013
Last updated December 10, 2013
Start date December 2013
Est. completion date August 2014

Study information

Verified date December 2013
Source Istanbul Medeniyet University
Contact Mehmet Kanbay, Associate Professor
Phone +902165709294
Email drkanbay@yahoo.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical 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. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility 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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
allopurinol 300 mg./day

Other:
No intervention

Drug:
Normouricemic


Locations

Country Name City State
Turkey Istanbul Medeniyet University Goztepe Training and Research Hospital Istanbul Marmara

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in insulin resistance (HOMA-IR) baseline and 3 months No
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