Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00256633
- Lead Sponsor
- US Department of Veterans Affairs
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 874
Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.
Patients not registered in the VADT.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be to determine if DNA characteristics are associated with CV risk in type 2 diabetes mellitus. End of study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Southern Arizona VA Health Care System, Tucson
🇺🇸Tucson, Arizona, United States
Edward Hines, Jr. VA Hospital
🇺🇸Hines, Illinois, United States
VA Medical Center, Lexington
🇺🇸Lexington, Kentucky, United States
VA Medical Center, Omaha
🇺🇸Omaha, Nebraska, United States
VA New Jersey Health Care System, East Orange
🇺🇸East Orange, New Jersey, United States
VA Medical Center, Salem VA
🇺🇸Salem, Virginia, United States
VA Medical Center, San Juan
🇵🇷San Juan, Puerto Rico
Richard Roudebush VA Medical Center, Indianapolis
🇺🇸Indianapolis, Indiana, United States
VA Medical Center, Minneapolis
🇺🇸Minneapolis, Minnesota, United States
VA San Diego Healthcare System, San Diego
🇺🇸San Diego, California, United States
Carl T. Hayden VA Medical Center
🇺🇸Phoenix, Arizona, United States
VA Central California Health Care System, Fresno
🇺🇸Fresno, California, United States
VA Medical Center, Miami
🇺🇸Miami, Florida, United States
VA Pittsburgh Health Care System
🇺🇸Pittsburgh, Pennsylvania, United States
VA Medical Center
🇺🇸Nashville, Tennessee, United States
VA South Texas Health Care System, San Antonio
🇺🇸San Antonio, Texas, United States