NCT00162799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

June 23, 2006

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

June 22, 2006

Conditions

Insulin Resistance

Keywords

insulin resistance and inflamationinsulin sensitibityobesity-induced insuline resistenceobesity-diabetes linksalicylateinsulin resistance in obesity health adults

Outcome Measures

Primary Outcomes (1)

  • Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).

Secondary Outcomes (1)

  • Reduction antropometric measures associated with insulin resistance and arterial hypertension.

Interventions

Triflusal (DCI)DRUG

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 35 to 60 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta

Girona, Girona, 17007, Spain

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

triflusal

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jose Manuel Fernández del Real, Dr

    Unidad Diabetología. Serv Endocrino Hosp Josep Trueta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

July 1, 2002

Study Completion

December 1, 2004

Last Updated

June 23, 2006

Record last verified: 2005-09

Locations

ES(1)