The Effect of Allopurinol on Insulin Resistance and Blood Pressure

Metabolic Syndrome Clinical Trial

Official title:

Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639756
• Other study ID #: IbSalut-M-001
• Status: Completed
• Phase: Phase 2
• First received: March 10, 2008
• Last updated: October 10, 2008
• Start date: June 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Hospital Mateo Orfila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males, age 40 -65 yrs

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Allopurinol
Allopurinol 300 mg
• Placebo
Placebo given for 2 weeks

Locations

Country	Name	City	State
Spain	Renal Unit, Mateo Orfila Hospital	Menorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Mateo Orfila

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance (HOMA index)		2 weeks	No
Primary	Blood pressure		2 weeks	No
Primary	Triglycerides, HDL cholesterol		2 weeks	No
Secondary	Adiponectin		2 weeks	No
Secondary	Leptin		2 weeks	No
Secondary	CRP level		2 weeks	No
Secondary	Weight gain		2 weeks	No