Effect of Allopurinol Treatment on Insulin Resistance

December 10, 2013 updated by: Mehmet Kanbay, Istanbul Medeniyet University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mehmet Kanbay, Associate Professor
  • Phone Number: +902165709294
  • Email: drkanbay@yahoo.com

Study Locations

  • Turkey
    • Marmara
      • Istanbul, Marmara, Turkey, 34353
        • Recruiting
        • Istanbul Medeniyet University Goztepe Training and Research Hospital
        • Contact:
          • Mehmet Kanbay, Associate Professor
          • Phone Number: +902165709294
          • Email: drkanbay@yahoo.com
        • Principal Investigator:
          • Mehmet Kanbay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Uric acid ≥7 mg/dL
This arm will receive allopurinol treatment. 50 subjects will be recruited.
Drug: allopurinol 300 mg./day
Active Comparator: Uric acid ≥6 and <7
This arm will not receive allopurinol. 50 subjects will be recruited.
Other: No intervention
Placebo Comparator: Normouricemic
This arm is healthy controls. 30 subjects will be recruited.
Drug: Normouricemic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in insulin resistance (HOMA-IR)
Time Frame: baseline and 3 months
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Investigators

  • Principal Investigator: Ali Bakan, Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

December 7, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Allo2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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