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The Effect of Allopurinol on Insulin Resistance and Blood Pressure

NCT ID: NCT00639756

Last Updated: 2008-10-13

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-10-31

Brief Summary

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Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.

Detailed Description

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60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.

Conditions

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Metabolic Syndrome

Keywords

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Uric acid Fructose Hypertension Insulin Glucose HOMA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Placebo

Group Type OTHER

Placebo

Intervention Type DRUG

Placebo given for 2 weeks

2

Allopurinol given for 2 weeks with diet

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Allopurinol 300 mg

Interventions

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Allopurinol

Allopurinol 300 mg

Intervention Type DRUG

Placebo

Placebo given for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males, age 40 -65 yrs

Exclusion Criteria

* None
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Mateo Orfila

OTHER

Sponsor Role lead

Responsible Party

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MATEO ORFILA HOSPITAL, University of Florida

Locations

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Renal Unit, Mateo Orfila Hospital

Menorca, Balearic Islands, Spain

Site Status

Countries

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Spain

References

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Johnson RJ, Perez-Pozo SE, Lillo JL, Grases F, Schold JD, Kuwabara M, Sato Y, Hernando AA, Garcia G, Jensen T, Rivard C, Sanchez-Lozada LG, Roncal C, Lanaspa MA. Fructose increases risk for kidney stones: potential role in metabolic syndrome and heat stress. BMC Nephrol. 2018 Nov 8;19(1):315. doi: 10.1186/s12882-018-1105-0.

Reference Type DERIVED
PMID: 30409184 (View on PubMed)

Perez-Pozo SE, Schold J, Nakagawa T, Sanchez-Lozada LG, Johnson RJ, Lillo JL. Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response. Int J Obes (Lond). 2010 Mar;34(3):454-61. doi: 10.1038/ijo.2009.259. Epub 2009 Dec 22.

Reference Type DERIVED
PMID: 20029377 (View on PubMed)

Other Identifiers

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IbSalut-M-001

Identifier Type: -

Identifier Source: org_study_id