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

This study has been completed.
Sponsor:
Information provided by:
J. Uriach and Company
ClinicalTrials.gov Identifier:
NCT00162799
First received: September 9, 2005
Last updated: June 22, 2006
Last verified: September 2005

September 9, 2005
June 22, 2006
July 2002
Not Provided
Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).
Same as current
Complete list of historical versions of study NCT00162799 on ClinicalTrials.gov Archive Site
Reduction antropometric measures associated with insulin resistance and arterial hypertension.
Same as current
Not Provided
Not Provided
 
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Insulin Resistance
Drug: Triflusal (DCI)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2004
Not Provided

Inclusion Criteria:

  • Ages 35 to 60 years old
Both
35 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00162799
ICO5TRI/2/01
Not Provided
Not Provided
J. Uriach and Company
Not Provided
Principal Investigator: Jose Manuel Fernández del Real, Dr Unidad Diabetología. Serv Endocrino Hosp Josep Trueta
J. Uriach and Company
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP