Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
CSP #465C - Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
2 other identifiers
observational
874
2 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
16 active sites
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
First Submitted
Initial submission to the registry
November 17, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 23, 2014
May 1, 2014
1.1 years
November 17, 2005
May 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome measure will be to determine if DNA characteristics are associated with CV risk in type 2 diabetes mellitus.
End of study.
Study Arms (1)
Group 1
enrolled in the ongoing randomized clinical trial AGlycemic Control and Complications in Diabetes Mellitus Type 2.
Eligibility Criteria
This is an observational study of patients who are enrolled in the ongoing randomized clinical trial AGlycemic Control and Complications in Diabetes Mellitus Type 2.
You may qualify if:
- Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.
You may not qualify if:
- Patients not registered in the VADT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- American Diabetes Associationcollaborator
Study Sites (16)
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
VA Central California Health Care System, Fresno
Fresno, California, 93703, United States
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
VA Medical Center, Miami
Miami, Florida, 33125, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884, United States
VA Medical Center, Lexington
Lexington, Kentucky, 40502, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
VA Medical Center, Omaha
Omaha, Nebraska, 68105-1873, United States
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, 07018, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
VA Medical Center
Nashville, Tennessee, 37212-2637, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229, United States
VA Medical Center, Salem VA
Salem, Virginia, 24153, United States
VA Medical Center, San Juan
San Juan, 00921, Puerto Rico
Biospecimen
Blood draws of DNA samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Angeliki Georgopoulos, MD
Minneapolis Veterans Affairs Medical Center
- STUDY CHAIR
Carlos Abraira, MD
Miami VA Healthcare System, Miami, FL
- STUDY CHAIR
William Duckworth, MD
Carl T. Hayden VA Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2005
First Posted
November 21, 2005
Study Start
April 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 23, 2014
Record last verified: 2014-05