Effect of Allopurinol Treatment on Insulin Resistance

NCT ID: NCT02008968

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperuricemia Prediabetes Insulin Resistance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Uric acid ≥7 mg/dL

This arm will receive allopurinol treatment. 50 subjects will be recruited.

Group Type ACTIVE_COMPARATOR

allopurinol 300 mg./day

Intervention Type DRUG

Uric acid ≥6 and <7

This arm will not receive allopurinol. 50 subjects will be recruited.

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

Normouricemic

This arm is healthy controls. 30 subjects will be recruited.

Group Type PLACEBO_COMPARATOR

Normouricemic

Intervention Type DRUG

Interventions

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allopurinol 300 mg./day

Intervention Type DRUG

No intervention

Intervention Type OTHER

Normouricemic

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Kanbay

Associate Professor Doctor Mehmet Kanbay

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Bakan

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Locations

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Istanbul Medeniyet University Goztepe Training and Research Hospital

Istanbul, Marmara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mehmet Kanbay, Associate Professor

Role: CONTACT

Phone: +902165709294

Email: [email protected]

Facility Contacts

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Mehmet Kanbay, Associate Professor

Role: primary

Other Identifiers

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Allo2013

Identifier Type: -

Identifier Source: org_study_id