Efficacy Pilot Study of Triflusal in the Attenuation of I... | NCT00162799

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

NCT00162799

Sponsor

J. Uriach and Company

Status

Completed

Last Update Posted

Jun 23, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Insulin Resistance

Interventions

Triflusal (DCI)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2006

Last Update Posted Date

Jun 23, 2006Estimated

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Triflusal (DCI)	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Reduction antropometric measures associated with insulin resistance and arterial hypertension.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 35 to 60 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose Manuel Fernández del Real, Dr	Unidad Diabetología. Serv Endocrino Hosp Josep Trueta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta		Girona	Girona	17007	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C016167	triflusal

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided