Back to resultsThe Effect of Allopurinol on Insulin Resistance and Blood Pressure
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Allopurinol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Uric acid, Fructose, Hypertension, Insulin, Glucose, HOMA
Eligibility Criteria
Inclusion Criteria:
- Males, age 40 -65 yrs
Exclusion Criteria:
- None
Sites / Locations
- Renal Unit, Mateo Orfila Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
1
2
Arm Description
Placebo
Allopurinol given for 2 weeks with diet
Outcomes
Primary Outcome Measures
Insulin resistance (HOMA index)
Blood pressure
Triglycerides, HDL cholesterol
Secondary Outcome Measures
Adiponectin
Leptin
CRP level
Weight gain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00639756
Brief Title
The Effect of Allopurinol on Insulin Resistance and Blood Pressure
Official Title
Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Mateo Orfila
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Uric acid, Fructose, Hypertension, Insulin, Glucose, HOMA
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Allopurinol given for 2 weeks with diet
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol 300 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo given for 2 weeks
Primary Outcome Measure Information:
Title
Insulin resistance (HOMA index)
Time Frame
2 weeks
Title
Blood pressure
Time Frame
2 weeks
Title
Triglycerides, HDL cholesterol
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Adiponectin
Time Frame
2 weeks
Title
Leptin
Time Frame
2 weeks
Title
CRP level
Time Frame
2 weeks
Title
Weight gain
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males, age 40 -65 yrs
Exclusion Criteria:
None
Facility Information:
Facility Name
Renal Unit, Mateo Orfila Hospital
City
Menorca
State/Province
Balearic Islands
ZIP/Postal Code
07703
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30409184
Citation
Johnson RJ, Perez-Pozo SE, Lillo JL, Grases F, Schold JD, Kuwabara M, Sato Y, Hernando AA, Garcia G, Jensen T, Rivard C, Sanchez-Lozada LG, Roncal C, Lanaspa MA. Fructose increases risk for kidney stones: potential role in metabolic syndrome and heat stress. BMC Nephrol. 2018 Nov 8;19(1):315. doi: 10.1186/s12882-018-1105-0.
Results Reference
derived
PubMed Identifier
20029377
Citation
Perez-Pozo SE, Schold J, Nakagawa T, Sanchez-Lozada LG, Johnson RJ, Lillo JL. Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response. Int J Obes (Lond). 2010 Mar;34(3):454-61. doi: 10.1038/ijo.2009.259. Epub 2009 Dec 22.
Results Reference
derived
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The Effect of Allopurinol on Insulin Resistance and Blood Pressure
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