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

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ClinicalTrials.gov Identifier: NCT00162799
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 23, 2006
Sponsor:
Information provided by:
J. Uriach and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: Triflusal (DCI) Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity
Study Start Date : July 2002
Estimated Study Completion Date : December 2004



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 35 to 60 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00162799     History of Changes
Other Study ID Numbers: ICO5TRI/2/01
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: June 23, 2006
Last Verified: September 2005

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:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Triflusal
Salicylates
Hypoglycemic Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action