Skip to main content
OpenTrials
Completed

NCT Number: NCT00639756

The Effect of Allopurinol on Insulin Resistance and Blood Pressure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Renal Unit, Mateo Orfila Hospital

Menorca, Balearic Islands, 07703, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males, age 40 -65 yrs

Exclusion criteria

  • None

Treatment and study plan

Allopurinol

Drug

Allopurinol 300 mg

Placebo

Drug

Placebo given for 2 weeks

Primary outcomes

  1. Insulin resistance (HOMA index)

    Time frame: 2 weeks

  2. Blood pressure

    Time frame: 2 weeks

  3. Triglycerides, HDL cholesterol

    Time frame: 2 weeks

Secondary outcomes

  1. Adiponectin

    Time frame: 2 weeks

  2. Leptin

    Time frame: 2 weeks

  3. CRP level

    Time frame: 2 weeks

  4. Weight gain

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Hospital Mateo Orfila

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 20, 2008
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.