Renal artery stenosis in patients with diabetes
| ISRCTN | ISRCTN99641923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99641923 |
| Protocol serial number | N/A |
| Sponsor | Changi General Hospital (Singapore) |
| Funder | Inlak Budhram Hospital (India) |
- Submission date
- 05/06/2012
- Registration date
- 18/06/2012
- Last edited
- 29/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Renal artery stenosis (RAS) is a narrowing of the arteries that carry blood to one or both of the kidneys. It is associated with an increased risk of high blood pressure and progression of kidney disease. However, in clinical practice, the presence of renal artery stenosis may be difficult to distinguish in patients with type 2 diabetes with kidney disease. This study was designed to find out about the prevalence of previously undetected renal artery stenosis in a group of South Asian patients with type 2 diabetes undergoing angiography for investigation of heart disease, and to find clinical characteristics that may aid in the identification of these patients.
Who can participate?
Patients with type 2 diabetes who are undergoing coronary angiography.
What does the study involve?
All recruited patients will have a renal angiography carried out at the same sitting as a coronary angiography.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part.
Where is the study run from?
Inlaks & Budhram Hospital, Pune, India.
When is the study starting and how long is it expected to run for?
The study started in January 2008 and ended in December 2008.
Who is funding the study?
Inlaks & Budhram Hospital, Pune, India
Who is the main contact?
Dr Eberta Tan
Eberta_Tan@cgh.com.sg
Contact information
Scientific
2 Simei Street 3
Singapore
529889
Singapore
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Prevalence and risk factors of renal artery stenosis in South Asian patients with type 2 diabetes using renal angiography |
| Study objectives | To determine the prevalence and risk factors of renal artery stenosis (RAS) in patients with type 2 diabetes. |
| Ethics approval(s) | Institutional Board of Inlak Budhram Hospital, Pune, India, December 2007 |
| Health condition(s) or problem(s) studied | Renal artery stenosis in patients with type 2 diabetes |
| Intervention | Statistical analysis The characteristics of patients with RAS were compared to those without RAS using Student's t-tests for continuous variables and Chi-Square or Fisher tests for comparison of categorical variables as appropriate. Univariate logistic regressions were performed to identify the factors associated with the presence of RAS. From the significant variables identified at this step, the backward stepwise method was used to identify variables that were independently associated with the outcome using the likelihood ratio test. Odds ratios and their corresponding 95% confidence intervals were presented as effect size. Tests for the appropriate assumptions for the models were carried out. Data was analyzed using SAS v9.2 (SAS Institute Inc., Cary, NC, USA) and the level of significance was set at 5%. Total duration of follow-up: 1 day |
| Intervention type | Other |
| Primary outcome measure(s) |
Prevalence of renal artery stenosis |
| Key secondary outcome measure(s) |
Risk factors of renal artery stenosis |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 249 |
| Key inclusion criteria | All consecutive patients with type 2 diabetes who underwent coronary angiography and who gave informed consent to be screened for renal artery stenosis at the same time were recruited into the study. The decision for coronary angiography was made by the consulting cardiologist based on a clinical indication of either symptomatic angina, ST-T alterations on the electrocardiogram or an acute myocardial infarction. |
| Key exclusion criteria | 1. Patients with known vasculitis 2. Renal artery stenosis 3. A serum creatinine level of >3.0 mg/dl or on renal replacement therapy |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- India
- Singapore
Study participating centre
529889
Singapore
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
