Cardiac Function and Microcirculation: Type 2 DIABetes and ECHOcardiographic Changes Over Time

NCT02956577 | Completed

• 1 other identifier: OUHSVB001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the influence of micro- and macrovascular changes on the cardiac function in relation to left ventricular function and coronary arteries during one year in patients with type 2 diabetes.

Conditions

Left Ventricular Dysfunction

Keywords

Global Longitudinal Strain (GLS); Coronary Flow Velocity Reserve (CFVR); Cardiac dysfunction; Microcirculation; Coronary Computed Tomography Angiography (CCTA); Type 1 Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Changes in Global Longitudinal Strain (GLS) stratified by Coronary Artery Calcium Score (CAC) in patients with diabetes during one year of follow-up

  To evaluate the changes in GLS stratified by CAC during one year of follow-up in patients with diabetes compared to non-diabetic subjects

  baseline, 12 months

Secondary Outcomes (9)

• Changes in GLS stratified by Coronary Flow Velocity Reserve (CFVR) in patients with diabetes during one year of follow-up

  baseline, 12 months

• Correlation between biomarkers and GLS stratified by CFVR

  12 months

• Correlation between biomarkers and GLS stratified by CAC

  12 months

• Changes in LV function stratified by CAC

  baseline, 12 months

• Changes in LV function stratified by CFVR

  baseline, 12 months

Other Outcomes (9)

• Relationship between strain values and framerate

  baseline, 12 months

• Relationship between strain values and omitted myocardial segments

  baseline, 12 months

• Correlation between dysglycaemia and Left Ventricle Mass (LVM)

  Baseline

Study Arms (3)

T2

Patients with type 2 diabetes without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were invited from the Outpatient Clinic of Endocrinology or The Eye Photo Clinic at Odense University Hospital (OUH) Svendborg. Diagnosis of diabetes was classified by trained endocrinologists according to international standards with relevant biochemistry. Historical data on urine- and blood samples as well as micro- and macrovascular diabetic complications have been registered consecutively in patients followed at the outpatient clinic in the regional Funen Diabetes Database (FDDB). Data on historical invasive procedures due to cardiac disease were registered in Western Denmark Heart Registry (WDHR).

T1

Patients with type 1 diabetes without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were invited from the Outpatient Clinic of Endocrinology or The Eye Photo Clinic at OUH Svendborg. Diagnosis of diabetes was classified by trained endocrinologists according to international standards with relevant biochemistry. Historical data on urine- and blood samples as well as micro- and macrovascular diabetic complications have been registered consecutively in patients followed at the outpatient clinic in the regional FDDB. Data on historical invasive procedures due to cardiac disease were registered in WDHR.

Non-diabetic subjects

Non-diabetic subjects without myocardial infarction, heart failure and symptoms of cardiac disease at inclusion, were included from The Danish Cardiovascular Screening trial (DANCAVAS). A randomized controlled trial with the primary aim to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for cardiovascular disease in men aged 65-74.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetes type 1+2 and non-diabetic subjects from the DANCAVAS trial (NCT00662480)

You may qualify if:

• Ability to give informed consent
• Estimated glomerular filtration rate (eGFR) \> 45 ml/min
• NYHA I + II

You may not qualify if:

• ° or 3° AV-block at baseline
• Long QT-syndrome at baseline
• Sinus node dysfunction with long sinus arrest at baseline
• Angina pectoris at baseline
• Ejection fraction (EF) \< 40% at baseline
• Atrial fibrillation at baseline
• Usage of dipyridamol at baseline
• Aortic stenosis and left ventricle hypertrophia at baseline
• Aortic insufficiency and left ventricle dilatation at baseline
• Medication for asthma within the last 4 years prior to baseline
• Medication for chronic obstructive pulmonary disease (COPD) at baseline
• Allergy to contrast agent at baseline
• Significant stenosis in left main (LM) / left anterior descending (LAD) artery at baseline
• Not feasible to measure or perform coronary flow velocity reserve (CFVR)
• Poor quality of echocardiographic images

Sponsors & Collaborators

• Svendborg Hospital: lead

Study Sites (1)

Cardiovascular Research Unit, OUH Svendborg Hospital

Svendborg, 5700, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Storage in biobank (-80° C): 5 x 2 ml (serum). 4 x 2 ml (ethylenediaminetetraacetic acid). 2 x 2 ml (sodium citrate) 1 x 2 ml (erythrocyte sedimentation rate)

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kenneth Egstrup, DMSci

  Odense University Hospital (OUH) Svendborg Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D-student

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 7, 2016
• Study Start: March 16, 2016
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)