Blood vessel problems in people with prediabetes and diabetes who have healthy heart arteries
| ISRCTN | ISRCTN15351014 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15351014 |
| Secondary identifying numbers | GHE 190 |
- Submission date
- 21/09/2024
- Registration date
- 23/09/2024
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Diabetes mellitus (DM) is a global health issue associated with increased heart disease risk. Endothelial dysfunction (narrowed blood vessels) is a known precursor to atherosclerosis (buildup of substances on blood vessel walls) and heart disease, and its role in DM complications is well-documented. There is limited information on endothelial (blood vessel wall) function in prediabetic patients evaluated using flow-mediated dilation (FMD), and studies have not excluded patients with known atherosclerosis or coronary artery disease. This study aimed to evaluate endothelial function using flow-mediated dilation from the brachial (upper arm) artery of DM and prediabetes patients who had normal coronary arteries.
Who can participate?
Patients aged 21-80 years evaluated in the Cardiology outpatient clinic who are found to have normal coronary arteries on coronary angiography, including patients with DM, prediabetes, and non-diabetics
What does the study involve?
The study involves the measurement of flow-mediated dilation of participants according to the established standard methods. The participants are divided into three groups according to their blood sugar status which is determined by measurement of blood glucose levels in the fasting state and after glucose loading.
What are the possible benefits and risks of participating?
The endothelial function of the brachial arteries of the participants will be measured using a noninvasive method. This will enable further determination of heart disease risk and preventive action. The glucose tolerance test and measurement of FMD using ultrasound from the brachial artery carries no risk for the participants.
Where is the study run from?
Ankara Guven Hospital (Türkiye)
When does the study start and how long is it expected to run for?
May 2008 to December 2010
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr İnci Aslı Atar, asliatar@gmail.com, inciasli.atar@saglik.gov.tr
Contact information
Public, Scientific, Principal Investigator
Ankara City Hospital
Ankara
06830
Türkiye
| Phone | +90 (0)3124572525 |
|---|---|
| inciasli.atar@saglik.gov.tr |
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Evaluation of endothelial dysfunction in prediabetes and diabetes mellitus in patients with normal coronary arteries using flow-mediated dilation of brachial artery |
| Study objectives | Diabetes mellitus (DM) is an important global pandemic disease and is associated with an increased incidence and mortality of cardiovascular disease. Endothelial dysfunction is considered a precursor to atherosclerosis and cardiovascular disease (CVD) and the role of endothelial dysfunction in the pathogenesis of both microvascular and macrovascular complications is well-documented in patients with DM. Prediabetes is an important diagnosis, enabling physicians to implement measures to prevent the progression to DM and its related complications or to slow the disease process. Evaluating endothelial function in prediabetic patients may allow for the early detection and treatment of issues before further complications arise. One of the most widely used non-invasive methods for assessing endothelial function in arteries is flow-mediated dilation (FMD) of the brachial artery. The relationship between the presence and severity of coronary artery disease and the degree of endothelial dysfunction is well established. Therefore, assessing endothelial function in a prediabetic population without excluding the presence of coronary artery disease presents limitations in demonstrating a causal relationship between endothelial dysfunction and prediabetes. Thus, this study aimed to evaluate the endothelial functions using FMD from the brachial artery of DM and prediabetes patients who had normal coronary arteries. |
| Ethics approval(s) |
Approved 23/12/2008, Ankara Guven Hospital Ethics Committee (Ankara Guven Hastanesi, Kavaklıdere, Simsek Sok. No: 29 Cankaya, Ankara, 06640, Türkiye; +90 (0)3124572525; guven@guven.com.tr), ref: 190 |
| Health condition(s) or problem(s) studied | Endothelial dysfunction in patients with diabetes and pre-diabetes with normal coronary arteries |
| Intervention | Patients evaluated in the Cardiology outpatient clinic who are found to have normal coronary arteries on coronary angiography will be included in the study. Diabetes and pre diabetes will be diagnosed according to American Diabetes Association criteria. Participants will be grouped as diabetic, pre diabetic and normal. Flow mediated dilation will be performed following the guidelines outlined in previously published literature by an investigator proficient in vascular ultrasound techniques. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Flow-mediated dilation is measured by an ultrasound system equipped with a 5-10 MHz linear array transducer from the brachial artery at baseline and after vasodilation, using an ultrasound, taken once per patient |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 04/05/2008 |
| Completion date | 30/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 73 |
| Key inclusion criteria | 1. Patients evaluated in the Cardiology outpatient clinic who were found to have normal coronary arteries on coronary angiography 2. Aged 21-80 years |
| Key exclusion criteria | 1. A history of previous percutaneous coronary intervention 2. Atrial fibrillation 3. Heart failure 4. More than mild valvular regurgitation 5. Valvular stenosis 6. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥90 mmHg in the last 6 weeks) 7. Cardiomyopathy 8. Chronic kidney or liver disease |
| Date of first enrolment | 25/12/2008 |
| Date of final enrolment | 30/10/2010 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Ankara
06690
Türkiye
Sponsor information
Hospital/treatment centre
Kavaklıdere, Şimşek Sokak NO: 29
Ankara
06640
Türkiye
| Phone | +90 (0)3124572525 |
|---|---|
| guven@guven.com.tr |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 10/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journal upon receival of registration number |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from the corresponding author (Dr İnci Aslı Atar, asliatar@gmail.com, inciasli.atar@saglik.gov.tr) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/11/2024 | 06/11/2024 | Yes | No |
Editorial Notes
06/11/2024: Publication reference added.
23/09/2024: Study's existence confirmed by Ankara Guven Hospital Ethics Committee.
