Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00256633
First received: November 17, 2005
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: CSP #465C - Fatty Acid Binding Protein 2 (FABP2) Ancillary Proposal

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome measure will be to determine if DNA characteristics are associated with CV risk in type 2 diabetes mellitus. [ Time Frame: End of study. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood draws of DNA samples.


Enrollment: 874
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
enrolled in the ongoing randomized clinical trial AGlycemic Control and Complications in Diabetes Mellitus Type 2.

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256633

Locations
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Central California Health Care System, Fresno
Fresno, California, United States, 93703
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, Tennessee
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
VA Medical Center, Salem VA
Salem, Virginia, United States, 24153
Puerto Rico
VA Medical Center, San Juan
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
American Diabetes Association
Investigators
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
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00256633     History of Changes
Other Study ID Numbers: 465C, 9066
Study First Received: November 17, 2005
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014