The Effect of Allopurinol on Insulin Resistance and Blood... | NCT00639756

Studies
The Effect of Allopurinol on Insulin Resistance and Blood Pressure

NCT00639756

Sponsor

Hospital Mateo Orfila

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Metabolic Syndrome

Interventions

Allopurinol
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Mar 10, 2008

First Submission Date that Met QC Criteria

Mar 19, 2008

First Posted Date

Mar 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Placebo	Drug: Placebo
2	Active Comparator	Allopurinol given for 2 weeks with diet	Drug: Allopurinol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allopurinol	Drug	Allopurinol 300 mg	2
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin resistance (HOMA index)		2 weeks
Blood pressure		2 weeks
Triglycerides, HDL cholesterol		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adiponectin		2 weeks
Leptin		2 weeks
CRP level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males, age 40 -65 yrs

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renal Unit, Mateo Orfila Hospital		Menorca	Balearic Islands	07703	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30409184	Derived	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.
20029377

ID	Term
D024821	Metabolic Syndrome
D006973	Hypertension
D007333	Insulin Resistance

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds