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NCT00162799 Clinical Trial

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

Insulin Resistance Clinical Trial

Official title:
Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00162799
Other study ID # ICO5TRI/2/01
Secondary ID
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated June 22, 2006
Start date July 2002
Est. completion date December 2004

Study information
Verified date September 2005
Source J. Uriach and Company
Contact n/a
Is FDA regulated No
Health authority Spain:Agencia Española del Medicamento
Study type Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

- Ages 35 to 60 years old

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Triflusal (DCI)

Locations
Country Name City State
Spain Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta Girona

Sponsors (1)
Lead Sponsor Collaborator
J. Uriach and Company

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).
Secondary Reduction antropometric measures associated with insulin resistance and arterial hypertension.
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