Is Glucagon-like Peptide-1 Insufficiency a Residual Risk in Coronary Artery Disease?
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|ClinicalTrials.gov Identifier: NCT02280837|
Recruitment Status : Unknown
Verified May 2016 by Sapporo Medical University.
Recruitment status was: Recruiting
First Posted : November 3, 2014
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Other: Determination of plasma GLP-1 level|
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 2013;8:e67578). 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 (i.e., 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 and/or 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 Type :||Observational|
|Estimated Enrollment :||220 participants|
|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?|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2018|
|Patients with suspected or diagnosed coronary artery disease||
Other: Determination of plasma GLP-1 level
Determination of GLP-1 level in samples of oral glucose tolerance tests
- Severity of coronary artery stenosis expressed as Gensini Score determined by coronary angiography [ Time Frame: at the time of coronary angiogram: Coronary angiogram will be performed on Hospital day 3 or a later day within 14 days after admission. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280837
|Contact: Tetsuji Miura, MD, PhD||81-11-611-2111 ext email@example.com|
|Contact: Takayuki Miki, MD, PhD||81-11-611-2111 ext firstname.lastname@example.org|
|Sapporo Medical University, School of Medicine||Recruiting|
|Sappro, Hokkaido, Japan, 0608556|
|Contact: Michiaki Yamakage, M.D.,PhD +81116112111 ext 3568 email@example.com|
|Principal Investigator: Michiaki Yamakage, M.D.,PhD|
|Principal Investigator:||Tetsuji Miura, MD, PhD||Sapporo Medical University|