Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02280837
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2014-10-26
Brief Title:
Is Glucagon-like Peptide-1 Insufficiency a Residual Risk in Coronary Artery Disease
Sponsor:
Sapporo Medical University
Organization:
Sapporo Medical University
Study Overview
Official Title:
An Observational Study to Examine the Relationship Between GLP-1 Insufficiency and Severity of Coronary Artery Disease in Patients Enrolled in BOREAS Registry a Prospective Registry of Cardiovascular and Renal Diseases Is GLP-1 Insufficiency a Residual Risk in Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2021-02
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:
In this study the investigators hypothesized that significant proportion of patients with coronary artery disease CAD has reduced capacity of glucagon-like peptide-1 GLP-1 secretion which is detectable as blunted response of plasma active GLP-1 level to oral glucose loading and that reduced GLP-1 secretory function is associated with increased severity of coronary artery stenosis but not with classic risk factors for CAD To test this hypothesis the investigators will analyze correlation between GLP-1 secretory capacity and severity of coronary artery stenosis determined by Gensini Score GS an established score system for coronary artery stenoses Additionally the investigators will analyze relationship between level of total GLP-1 and severity of coronary artery stenosis to determine how it is different from the active GLP-1 - coronary stenosis relationship
Detailed Description:
Recently the investigators found that a significant proportion of subjects in a general population shows attenuated secretion of active GLP-1 in response to oral glucose loading and that the insufficient secretion of GLP-1 was independently associated with elevation of blood pressure BP Yoshihara et al PLoS One 20138e67578 In that study it was also found that the amount of GLP-1 secreted after glucose loading was not correlated with any of conventional serum lipid parameters ie triglyceride LDL-cholesterol and HDL-cholesterol or plasma insulin level These findings suggest that insufficiency of GLP-1 secretion may promote atherosclerosis and formation of coronary plaques Furthermore lack of correlation between response of active GLP-1 secretion and serum lipids or plasma insulin indicates that insufficient secretion of active GLP-1 may be a hidden risk factor of atherosclerotic vascular disease Based on those results in a previous study the investigators designed the present study
The present study is a single-centered Sapporo Medical University Hospital observational study enrolling patients who will be admitted to our institute for coronary angiogram Written informed consent will be obtained from patients on admission Patients will receive demographic measurements blood sampling for routine serum biochemistry and detailed analyses of serum lipids such as apolipoproteins remnant-like lipoprotein particle and oxidized-LDL-cholesterol after overnight fast and oral glucose tolerance test OGTT In OGTT blood will be sampled for assay of glucose insulin active GLP-1 and total GLP-1 before 30 min 60 min and 120 min after oral 75 g-glucose loading Capacity of GLP-1 secretion will be determined as area under the curve of plasma GLP-1 level AUC-GLP-1 All study subjects will undergo coronary angiogram and severity of coronary artery stenosis will be quantified by Gensini score GS Relationship between GS AUC-active-GLP-1 or AUC-total-GLP-1 blood pressure serum lipid parameters and indices of insulin resistance homeostasis model assessment as an index of insulin resistance and Matsuda-Defronzo index will be examined by use of univariate and multivariate regression analyses to determine whether AUC-active-GLP-1 or AUC-total-GLP-1 is an independent determinant of coronary artery stenosis This study will be conducted as one of projects in BOREAS registry a non-interventional multicenter registry of cardiovascular andor renal diseases conducted by our institute and affiliated hospitals
The time frame for which the outcome measures is assessed Informed consent on Hospital day 1 Demographic examinations and blood and urine tests on Hospital day 1 and day 2 OGTT on Hospital day 2 or day 3 Coronary angiogram and scoring coronary stenoses on Hospital day 3 or a later day within 14 days after admission patients who could not undergo angiogram within 14 days after admission by incidental causes will be excluded Acquisition of data necessary for analyses on Day 9-17 Data set of each patients including remnant-like protein particle ApoA1 ApoB and ApoE will be mostly completed within approximately 9-17 days after admission Samples for determination of GLP-1 will be stored at -80 C until assay
The present study is a single-centered Sapporo Medical University Hospital observational study enrolling patients who will be admitted to our institute for coronary angiogram Written informed consent will be obtained from patients on admission Patients will receive demographic measurements blood sampling for routine serum biochemistry and detailed analyses of serum lipids such as apolipoproteins remnant-like lipoprotein particle and oxidized-LDL-cholesterol after overnight fast and oral glucose tolerance test OGTT In OGTT blood will be sampled for assay of glucose insulin active GLP-1 and total GLP-1 before 30 min 60 min and 120 min after oral 75 g-glucose loading Capacity of GLP-1 secretion will be determined as area under the curve of plasma GLP-1 level AUC-GLP-1 All study subjects will undergo coronary angiogram and severity of coronary artery stenosis will be quantified by Gensini score GS Relationship between GS AUC-active-GLP-1 or AUC-total-GLP-1 blood pressure serum lipid parameters and indices of insulin resistance homeostasis model assessment as an index of insulin resistance and Matsuda-Defronzo index will be examined by use of univariate and multivariate regression analyses to determine whether AUC-active-GLP-1 or AUC-total-GLP-1 is an independent determinant of coronary artery stenosis This study will be conducted as one of projects in BOREAS registry a non-interventional multicenter registry of cardiovascular andor renal diseases conducted by our institute and affiliated hospitals
The time frame for which the outcome measures is assessed Informed consent on Hospital day 1 Demographic examinations and blood and urine tests on Hospital day 1 and day 2 OGTT on Hospital day 2 or day 3 Coronary angiogram and scoring coronary stenoses on Hospital day 3 or a later day within 14 days after admission patients who could not undergo angiogram within 14 days after admission by incidental causes will be excluded Acquisition of data necessary for analyses on Day 9-17 Data set of each patients including remnant-like protein particle ApoA1 ApoB and ApoE will be mostly completed within approximately 9-17 days after admission Samples for determination of GLP-1 will be stored at -80 C until assay
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