Narrowing of the main artery by the build-up of calcium in patients with type 2 diabetes
| ISRCTN | ISRCTN13124221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13124221 |
| Secondary identifying numbers | B180900053 |
- Submission date
- 18/04/2020
- Registration date
- 20/04/2020
- Last edited
- 20/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high. It's caused by problems with a chemical in the body (hormone) called insulin. It's often linked to being overweight or inactive, or having a family history of type 2 diabetes. Type 2 diabetes accelerates atherosclerosis and increases cardiovascular disease (CVD) morbidity including coronary artery disease (CAD), cerebral infarction (CI), and peripheral artery disease (PAD). The clinical assessment of cardiovascular risk in individual patients with type 2 diabetes is required for proper management. However, little is known about the significance of each clinical indicator in estimating disease progression.
The aorta is the main artery of the body, supplying oxygenated blood to the circulatory system. Abdominal aortic calcification occurs when calcium crystals are deposited in the abdominal aorta. This can cause the aorta to narrow and restrict blood flow. Abdominal aortic calcification (AAC) is a known marker of systemic atherosclerosis burden. The risk of AAC is reportedly lower among Hispanic and African Americans, but not among Chinese-Americans, compared with the risk in Caucasians. These ethnic differences in the significance of AAC cannot be explained by differences in classical CVD risk factors. The prevalence of coronary calcification also reportedly differs between Caucasians and Chinese, despite similar prevalences of AAC in these two ethnic groups. Few studies have investigated the clinical significance of AAC in patients with type 2 diabetes.
In this study, the researchers investigated the association between AAC and CVD and explored factors related to AAC progression in Japanese patients with type 2 diabetes.
Who can participate?
Adults aged 20 or over with type 2 diabetes.
What does the study involve?
Participants who had undergone a standing lateral abdominal radiography examination between 2 months before and 2 months after admission were eligible for inclusion in this study. AAC was evaluated using two methods, AAC score and AAC length, based on the results of standing lateral abdominal radiography examinations.
What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. Risks relate to radiation, but they are relatively low.
Where is the study run from?
Yokohama Coty University Hospital (Japan)
When is the study starting and how long is it expected to run for?
January 2016 to March 2018
Who is funding the study?
The Japan Society for the Promotion of Science
Who is the main contact?
Jun Shirakawa, MD, PhD
jshira-tky@umin.ac.jp
Contact information
Scientific
Yokohama City University
Fuku-ura 3-9
Kanazawa-ku
Yokohama
236-0004
Japan
 ORCID ID |
0000-0002-0822-8750 |
|---|---|
| Phone | +81 (0)457872639 |
| jshira-tky@umin.ac.jp |
Study information
| Study design | Retrospective cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not aveilable in web format, please use contact details to request a participant information sheet |
| Scientific title | Association of abdominal aortic calcification with coronary artery disease or other factors in type 2 diabetes |
| Study acronym | AAC in T2D |
| Study objectives | Abdominal aortic calcification is associated with cardiovascular disease morbidity in patients with type 2 diabetes |
| Ethics approval(s) | Approved 12/10/2018, Clinical Ethics Committee of Yokohama City University (Fuku-ura 3-9, Kanazawa-ku, Yokohama 236-0004, Japan; +81-45-370-7627; rinri@yokohama-cu.ac.jp), ref: B180900053 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | The subjects included Japanese type 2 diabetes patients who had been hospitalized at Yokohama City University Hospital between January 1, 2016, and March 31, 2018. The lateral view of an abdominal X-ray image obtained while each subject was in a standing position will be examined, and the AAC score and AAC length, corresponding to the area of calcific deposits in the anterior and posterior aortic wall for the L1-4 and L1-5 regions, respectively, measured. The associations between the AAC scores and lengths and the presence of coronary artery disease, cerebral infarction, and peripheral artery disease are then assessed. The correlation between the AAC grades and other clinical factors are also evaluated. |
| Intervention type | Other |
| Primary outcome measure | Measured using patient records at the time of data collection: 1. AAC score 2. AAC length 3. Presence of cardiovascular diseases, such as CAD, CI, and PAD |
| Secondary outcome measures | Factors associated with AAC score or AAC length measured using patient records at the time of data collection |
| Overall study start date | 15/10/2018 |
| Completion date | 02/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 285 |
| Total final enrolment | 285 |
| Key inclusion criteria | 1. Japanese type 2 diabetes patients who had been hospitalized at Yokohama City University Hospital between January 1, 2016, and March 31, 2018. 2. Aged 20 years or older 2. Undergone a standing lateral abdominal radiography examination between 2 months before and 2 months after admission |
| Key exclusion criteria | 1. Severe hepatic disorders 2. Psychiatric disorders 3. Cancers 4. Severe ketosis, diabetic coma or precoma 5. Severe infections 6. Severe traumatic injuries 7. Pancreatic exocrine diseases 8. Hepatic cirrhosis 9. Endocrine diseases 10. Postoperative patients |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 31/03/2018 |
Locations
Countries of recruitment
- Japan
Study participating centre
Kanazawa-ku
Yokohama
236-0004
Japan
Sponsor information
University/education
Fuku-ura 3-9
Kanazawa-ku
Yokohama
236-0004
Japan
| Phone | +81 (0)457872639 |
|---|---|
| jshira-tky@umin.ac.jp | |
| Website | http://www.yokohama-cu.ac.jp/index-e.html |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
20/04/2020: Trial’s existence confirmed by Clinical Ethics Committee of Yokohama City University.
