Is Glucagon-like Peptide-1 Insufficiency a Residual Risk in Coronary Artery Disease?

NCT02280837 | Completed

• 1 other identifier: 262-83
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

GLP-1

Outcome Measures

Primary Outcomes (1)

• Severity of coronary artery stenosis expressed as Gensini Score determined by coronary angiography

  at the time of coronary angiogram: Coronary angiogram will be performed on Hospital day 3 or a later day within 14 days after admission.

Study Arms (1)

Patients with suspected or diagnosed coronary artery disease

Other: Determination of plasma GLP-1 level

Interventions

Determination of plasma GLP-1 level OTHER

Determination of GLP-1 level in samples of oral glucose tolerance tests

Patients with suspected or diagnosed coronary artery disease

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-diabetic patients with suspected or diagnosed CAD who are hospitalized for coronary angiogram will be enrolled in this study. The patients are expected to be similar to those who have visited our institute recently; approximately 28% of patients with CAD are diabetics, and one third of them are medically untreated at the time of their first visit. In recent years, 500-600 patients have undergone coronary angiography per year in this institute, and approximately 50% of them were without history of percutaneous coronary interventions (PCI) or coronary bypass surgery. Hence, approximately 180-210 patients per year will be candidates for the present project.

You may not qualify if:

• Diabetic patients whose HbA1c is higher than 6.5% or who have received insulin or hypoglycemic agents and those who need immediate pharmacological treatments after admission will be excluded.
• Patients with history of PCI also will be excluded.

Sponsors & Collaborators

• Sapporo Medical University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Sapporo Medical University, School of Medicine

Sapporo, Hokkaido, 0608556, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tetsuji Miura, MD, PhD

  Sapporo Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: November 3, 2014
• Study Start: February 27, 2015
• Primary Completion: March 27, 2019
• Study Completion: December 29, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

JP (1)