NCT00639756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

Enrollment Period

2 months

First QC Date

March 10, 2008

Last Update Submit

October 10, 2008

Conditions

Metabolic Syndrome

Keywords

Uric acidFructoseHypertensionInsulinGlucoseHOMA

Outcome Measures

Primary Outcomes (3)

  • Insulin resistance (HOMA index)

    2 weeks

  • Blood pressure

    2 weeks

  • Triglycerides, HDL cholesterol

    2 weeks

Secondary Outcomes (4)

  • Adiponectin

    2 weeks

  • Leptin

    2 weeks

  • CRP level

    2 weeks

  • Weight gain

    2 weeks

Study Arms (2)

1

OTHER

Placebo

Drug: Placebo

2

ACTIVE COMPARATOR

Allopurinol given for 2 weeks with diet

Drug: Allopurinol

Interventions

AllopurinolDRUG

Allopurinol 300 mg

2
PlaceboDRUG

Placebo given for 2 weeks

1

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males, age 40 -65 yrs

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Unit, Mateo Orfila Hospital

Menorca, Balearic Islands, 07703, Spain

Location

Related Publications (2)

  • 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.

    PMID: 30409184DERIVED

  • 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.

    PMID: 20029377DERIVED

MeSH Terms

Conditions

Metabolic SyndromeHypertensionInsulin Resistance

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 20, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2008

Study Completion

October 1, 2008

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations

ES(1)