Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal

Type 2 Diabetes Mellitus Clinical Trial

Official title:

CSP #465C - Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256633
• Other study ID #: 465C
• Secondary ID: 9066
• Status: Completed
• Phase: N/A
• First received: November 17, 2005
• Last updated: May 21, 2014
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

TITLE: CSP 465-C, Fatty Acid Binding protein 2 (FABP2) ancillary proposal to CSP# 465 Glycemic Control and Complications in Diabetes Mellitus Type 2.

Angeliki Georgopoulos, M.D. Carlos Abraira M.D. William Duckworth M.D.

Fatty acid binding protein 2 (FABP2) is involved in the transport of long chain fatty acids across the intestinal epithelium. A common (40-45%) polymorphism of FABP2 gene (codon 54 Threonine for Alanine) results in increased intestinal fatty acid absorption and triglyceride secretion (Baier et al J Clin Invest 95:1281-87, 1995; Baier et al J Biol Chem 271: 10892-10896,1996). We have found (JCEM 85:3155-60, 2000) that in patients with type 2 diabetes, the codon 54 polymorphism of the FABP2 results in fasting and postprandial hypertriglyceridemia. Since hypertriglyceridemia is a risk factor for atherosclerosis in type 2 diabetes and it is part of the insulin resistance syndrome, the objective of this ancillary study would be to screen the participants of the CSP# 465 study for the polymorphism and assess a) whether those carrying the polymorphism respond differently to the various treatment modalities and b) whether they develop more cardiovascular events compared to the ones lacking the polymorphism. There is one study that suggests an association of the polymorphism with a history of parental stroke (JCEM 85:2801-4, 2000).

The only additional request from the study participants will be to agree to the collection of a blood sample to be used for DNA isolation and screening for the polymorphism. No additional funds are requested. If this polymorphism proves to be a predictor of either the response to a specific treatment modality or of the risk to macro-vascular complications, it will be very easy to screen for it and target our treatment modalities appropriately.

Description:

Primary Hypothesis:

Secondary Hypotheses:

Primary Outcomes: Major cardiovascular events

Study Abstract:

TITLE: CSP 465-C, Fatty Acid Binding protein 2 (FABP2) ancillary proposal to CSP# 465 Glycemic Control and Complications in Diabetes Mellitus Type 2.

Angeliki Georgopoulos, M.D. Carlos Abraira M.D. William Duckworth M.D.

Fatty acid binding protein 2 (FABP2) is involved in the transport of long chain fatty acids across the intestinal epithelium. A common (40-45%) polymorphism of FABP2 gene (codon 54 Threonine for Alanine) results in increased intestinal fatty acid absorption and triglyceride secretion (Baier et al J Clin Invest 95:1281-87, 1995; Baier et al J Biol Chem 271: 10892-10896,1996). We have found (JCEM 85:3155-60, 2000) that in patients with type 2 diabetes, the codon 54 polymorphism of the FABP2 results in fasting and postprandial hypertriglyceridemia. Since hypertriglyceridemia is a risk factor for atherosclerosis in type 2 diabetes and it is part of the insulin resistance syndrome, the objective of this ancillary study would be to screen the participants of the CSP# 465 study for the polymorphism and assess a) whether those carrying the polymorphism respond differently to the various treatment modalities and b) whether they develop more cardiovascular events compared to the ones lacking the polymorphism. There is one study that suggests an association of the polymorphism with a history of parental stroke (JCEM 85:2801-4, 2000).

The only additional request from the study participants will be to agree to the collection of a blood sample to be used for DNA isolation and screening for the polymorphism. No additional funds are requested. If this polymorphism proves to be a predictor of either the response to a specific treatment modality or of the risk to macro-vascular complications, it will be very easy to screen for it and target our treatment modalities appropriately.

The data was not analyzed therefore there will be no results for this record/study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 874
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.

Exclusion Criteria:

Patients not registered in the VADT.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Puerto Rico	VA Medical Center, San Juan	San Juan
United States	VA New Jersey Health Care System, East Orange	East Orange	New Jersey
United States	VA Central California Health Care System, Fresno	Fresno	California
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana
United States	VA Medical Center, Lexington	Lexington	Kentucky
United States	VA Medical Center, Miami	Miami	Florida
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	VA Medical Center	Nashville	Tennessee
United States	VA Medical Center, Omaha	Omaha	Nebraska
United States	Carl T. Hayden VA Medical Center	Phoenix	Arizona
United States	VA Pittsburgh Health Care System	Pittsburgh	Pennsylvania
United States	VA Medical Center, Salem VA	Salem	Virginia
United States	VA South Texas Health Care System, San Antonio	San Antonio	Texas
United States	VA San Diego Healthcare System, San Diego	San Diego	California
United States	Southern Arizona VA Health Care System, Tucson	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	American Diabetes Association

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be to determine if DNA characteristics are associated with CV risk in type 2 diabetes mellitus.		End of study.	No