The Effect of Allopurinol on Insulin Resistance and Blood Pressure

• Sponsor: Hospital Mateo Orfila (Other)
• Overall Status: Completed
• CT.gov ID: NCT00639756
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Drug: Allopurinol; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Placebo	Drug: Placebo; Placebo given for 2 weeks
Active Comparator: 2 Allopurinol given for 2 weeks with diet	Drug: Allopurinol; Allopurinol 300 mg

Outcome Measures

Primary Outcome Measures

1. Insulin resistance (HOMA index) [2 weeks]

2. Blood pressure [2 weeks]

3. Triglycerides, HDL cholesterol [2 weeks]

Secondary Outcome Measures

1. Adiponectin [2 weeks]

2. Leptin [2 weeks]

3. CRP level [2 weeks]

4. Weight gain [2 weeks]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Males, age 40 -65 yrs

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renal Unit, Mateo Orfila Hospital	Menorca	Balearic Islands	Spain	07703

Sponsors and Collaborators

• Hospital Mateo Orfila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00639756
• Other Study ID Numbers: IbSalut-M-001
• First Posted: Mar 20, 2008
• Last Update Posted: Oct 13, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: Uric acid; Fructose; Hypertension; Insulin; Glucose; HOMA
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Allopurinol

Study Results

No Results Posted as of Oct 13, 2008