Back to resultsEfficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
Primary Purpose
Insulin Resistance
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Triflusal (DCI)
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring insulin resistance and inflamation, insulin sensitibity, obesity-induced insuline resistence, obesity-diabetes link, salicylate, insulin resistance in obesity health adults
Eligibility Criteria
Inclusion Criteria: Ages 35 to 60 years old
Sites / Locations
- Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00162799
Brief Title
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
Official Title
Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
J. Uriach and Company
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
insulin resistance and inflamation, insulin sensitibity, obesity-induced insuline resistence, obesity-diabetes link, salicylate, insulin resistance in obesity health adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Triflusal (DCI)
Primary Outcome Measure Information:
Title
Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR).
Secondary Outcome Measure Information:
Title
Reduction antropometric measures associated with insulin resistance and arterial hypertension.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 35 to 60 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Manuel Fernández del Real, Dr
Organizational Affiliation
Unidad Diabetología. Serv Endocrino Hosp Josep Trueta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unitat de Diabetologia, Endocrinologia y Nutrición Hosp Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity
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