The Effect of Allopurinol on Insulin Resistance and Blood Pressure
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion |
- 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 ]
- 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
|
|
Active Comparator: 2
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 |
Inclusion Criteria:
- Males, age 40 -65 yrs
Exclusion Criteria:
- None
Contacts and Locations More Information
No publications provided by Hospital Mateo Orfila
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | PEREZ-POZO, SANTOS E. LOPEZ-LILLO, JULIAN. JOHNSON, RICHARD, MATEO ORFILA HOSPITAL, University of Florida |
| ClinicalTrials.gov Identifier: | NCT00639756 History of Changes |
| Other Study ID Numbers: | IbSalut-M-001 |
| Study First Received: | March 10, 2008 |
| Last Updated: | October 10, 2008 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Mateo Orfila:
|
Uric acid Fructose Hypertension |
Insulin Glucose HOMA |
Additional relevant MeSH terms:
|
Insulin Resistance Metabolic Syndrome X Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Allopurinol Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013