The Effect of Allopurinol on Insulin Resistance and Blood Pressure - Full Text View

Sponsored by:	Hospital Mateo Orfila
Information provided by:	Hospital Mateo Orfila
ClinicalTrials.gov Identifier:	NCT00639756

Purpose

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.

Condition	Intervention	Phase
Metabolic Syndrome	Drug: Allopurinol Drug: Placebo	Phase II

Drug Information available for: Insulin Dextrose Fructose Allopurinol Allopurinol sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion

Further study details as provided by Hospital Mateo Orfila:

Primary Outcome Measures:

Insulin resistance (HOMA index) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Triglycerides, HDL cholesterol [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adiponectin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Leptin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
CRP level [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Weight gain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2008
Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Placebo	Drug: Placebo Placebo given for 2 weeks
2: Active Comparator Allopurinol given for 2 weeks with diet	Drug: Allopurinol Allopurinol 300 mg

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males, age 40 -65 yrs

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639756

Locations

Spain, Balearic Islands
Renal Unit, Mateo Orfila Hospital
Menorca, Balearic Islands, Spain, 07703

Sponsors and Collaborators

Hospital Mateo Orfila

More Information

Responsible Party:	MATEO ORFILA HOSPITAL, University of Florida ( PEREZ-POZO, SANTOS E. LOPEZ-LILLO, JULIAN. JOHNSON, RICHARD )
Study ID Numbers:	IbSalut-M-001
Study First Received:	March 10, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00639756
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Mateo Orfila:

Uric acid
Fructose
Hypertension

Insulin
Glucose
HOMA

Study placed in the following topic categories:

Uric Acid
Allopurinol
Insulin Resistance
Insulin
Hypertension

Additional relevant MeSH terms:

Antimetabolites
Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Gout Suppressants

Protective Agents
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Free Radical Scavengers
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009