Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity

NCT ID: NCT00162799

Last Updated: 2006-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-12-31

Brief Summary

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To explore the efficacy of triflusal in the attenuation of insulin resistance in human obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced insulin resistance by triflusal.

Detailed Description

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Double-blind, randomized, cross-over (three periods) with two dose levels of triflusal, placebo-controlled.

Interventions: treatment periods Triflusal 600 mg/d, 15 days Triflusal 900 mg/d , 15 days placebo, 15 days

Washout period: 30 days

Conditions

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Insulin Resistance

Keywords

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insulin resistance and inflamation insulin sensitibity obesity-induced insuline resistence obesity-diabetes link salicylate insulin resistance in obesity health adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Triflusal (DCI)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 35 to 60 years old
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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J. Uriach and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jose Manuel Fernández del Real, Dr

Role: PRINCIPAL_INVESTIGATOR

Unidad Diabetología. Serv Endocrino Hosp Josep Trueta

Locations

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Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta

Girona, Girona, Spain

Site Status

Countries

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Spain

Other Identifiers

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ICO5TRI/2/01

Identifier Type: -

Identifier Source: org_study_id