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

This study has been completed.
Information provided by:
J. Uriach and Company
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: June 22, 2006
Last verified: September 2005
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.

Condition Intervention Phase
Insulin Resistance
Drug: Triflusal (DCI)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity

Resource links provided by NLM:

Further study details as provided by J. Uriach and Company:

Primary Outcome Measures:
  • Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).

Secondary Outcome Measures:
  • Reduction antropometric measures associated with insulin resistance and arterial hypertension.

Estimated Enrollment: 30
Study Start Date: July 2002
Estimated Study Completion Date: December 2004
Detailed Description:

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


Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ages 35 to 60 years old
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00162799

Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta
Girona, Spain, 17007
Sponsors and Collaborators
J. Uriach and Company
Principal Investigator: Jose Manuel Fernández del Real, Dr Unidad Diabetología. Serv Endocrino Hosp Josep Trueta
  More Information

ClinicalTrials.gov Identifier: NCT00162799     History of Changes
Other Study ID Numbers: ICO5TRI/2/01 
Study First Received: September 9, 2005
Last Updated: June 22, 2006
Health Authority: Spain:Agencia Española del Medicamento

Keywords provided by J. Uriach and Company:
insulin resistance and inflamation
insulin sensitibity
obesity-induced insuline resistence
obesity-diabetes link
insulin resistance in obesity health adults

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 23, 2016