Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Insulin (Drug); Glimepiride (Drug); Rosiglitazone (Drug); Metformin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Angeliki Georgopoulos, MD, Principal Investigator, Affiliation: Minneapolis VAMC
Carlos Abraira, MD, Study Chair, Affiliation: Miami VAMC
William Duckworth, MD, Study Chair, Affiliation: Phoenix VAMC
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.
Clinical Details
Official title: CSP #465C - Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral
agents.
Locations and Contacts
Vamc - San Juan, Pr, San Juan 00921, Puerto Rico
Vamc - Tucson, Az, Tucson, Arizona 85723, United States
Vamc - Phoenix, Az, Phoenix, Arizona 85012, United States
Vamc Medical Center - Fresno, Fresno, California 93703, United States
Vamc - San Diego, Ca, San Diego, California 92161, United States
Vamc - Miami, Fl, Miami, Florida 33125, United States
Vamc - Hines, Il, Hines, Illinois 60141, United States
Vamc - Indianapolis, in, Indianapolis, Indiana 46202, United States
Vamc - Lexington, Ky, Lexington, Kentucky 40511-1093, United States
Vamc - Minneapolis, Mn, Minneapolis, Minnesota 55417, United States
Vamc - Omaha, Ne, Omaha, Nebraska 68105, United States
Vamc New Jersey Healthcare System, Lyons, New Jersey 07939, United States
Vamc - Pittsburgh, Pa, Pittsburgh, Pennsylvania 15261, United States
Vamc - Nashville, Tn, Nashville, Tennessee 37232-6303, United States
Vamc - San Antonio, Tx, San Antonio, Texas 78284, United States
Vamc - Salem, Va, Salem, Virginia 24153, United States
Additional Information
Ending date: November 2007
Last updated: September 24, 2007
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