Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256633
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-11-17
Brief Title:
Fatty Acid Binding Protein 2 FABP2 Ancillary Proposal
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 465C - Fatty Acid Binding Protein 2 FABP2 Ancillary Proposal
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MD Carlos Abraira MD William Duckworth MD
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 951281-87 1995 Baier et al J Biol Chem 271 10892-108961996 We have found JCEM 853155-60 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 852801-4 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
Angeliki Georgopoulos MD Carlos Abraira MD William Duckworth MD
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 951281-87 1995 Baier et al J Biol Chem 271 10892-108961996 We have found JCEM 853155-60 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 852801-4 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 MD Carlos Abraira MD William Duckworth MD
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 951281-87 1995 Baier et al J Biol Chem 271 10892-108961996 We have found JCEM 853155-60 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 852801-4 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 recordstudy
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 MD Carlos Abraira MD William Duckworth MD
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 951281-87 1995 Baier et al J Biol Chem 271 10892-108961996 We have found JCEM 853155-60 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 852801-4 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 recordstudy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9066 | OTHER_GRANT | Minnesota Medical Foundataion | None |