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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
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

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

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

No publications provided

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
salicylate
insulin resistance in obesity health adults

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Insulin
Triflusal
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013