Clinical trial NCT00256633: Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
Official title: CSP #465C - Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: American Diabetes Association
First posted: 2005-11-21
Enrollment: 874
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome measure will be to determine if DNA characteristics are associated with CV risk in type 2 diabetes mellitus.
timeFrame: End of study.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T. Hayden VA Medical Center
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System, Tucson
state: Arizona
city: Fresno
country: United States
facility: VA Central California Health Care System, Fresno
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Richard Roudebush VA Medical Center, Indianapolis
state: Indiana
city: Lexington
country: United States
facility: VA Medical Center, Lexington
state: Kentucky
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Omaha
country: United States
facility: VA Medical Center, Omaha
state: Nebraska
city: East Orange
country: United States
facility: VA New Jersey Health Care System, East Orange
state: New Jersey
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
city: Nashville
country: United States
facility: VA Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: VA South Texas Health Care System, San Antonio
state: Texas
city: Salem
country: United States
facility: VA Medical Center, Salem VA
state: Virginia
city: San Juan
country: Puerto Rico
facility: VA Medical Center, San Juan
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Angeliki Georgopoulos, MD
role: STUDY_CHAIR
affiliation: Miami VA Healthcare System, Miami, FL
name: Carlos Abraira, MD
role: STUDY_CHAIR
affiliation: Carl T. Hayden VA Medical Center
name: William Duckworth, MD
role: STUDY_CHAIR
References: