Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity|
- Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).
- Reduction antropometric measures associated with insulin resistance and arterial hypertension.
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||December 2004|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162799
|Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta|
|Girona, Spain, 17007|
|Principal Investigator:||Jose Manuel Fernández del Real, Dr||Unidad Diabetología. Serv Endocrino Hosp Josep Trueta|