This document outlines a study on the prevalence of asymptomatic bacteriuria in type 2 diabetic patients at a tertiary care hospital in Chennai. The study aims to determine the prevalence of asymptomatic bacteriuria, analyze the organisms responsible and their antimicrobial sensitivity, and examine associations between asymptomatic bacteriuria and patient characteristics like age and diabetes duration. A cross-sectional study of 200 type 2 diabetic outpatients will collect urine samples to test for bacteriuria and blood samples for glucose and HbA1c levels. Appropriate consent will be obtained and precautions taken to minimize risks and protect patient privacy.

1. A STUDY OF PREVALENCE OF
ASYMPTOMATIC BACTERIURIA IN
TYPE 2 DIABETIC PATIENTS IN A
TERTIARY CARE HOSPITAL IN
CHENNAI
INVESTIGATOR:
Dr.S.ANBALAGAN
JR - Department of General Medicine SBMCH
GUIDE :
DR. A.SANKAR
Associate Professor
Department of General Medicine, SBMCH
DR. UMASHANKAR
Asst. Professor
Department of General Medicine, SBMCH

2. INTRODUCTION
 Type 2 diabetes mellitus is the commonest form of the
disease, accounting for 85-95% of all cases worldwide
and affecting 5-7% of the world's population.
 Diabetes produces various acute and chronic
complications
 Diabetes is associated with increased risk of developing
infection, increased severity of infection and prolonged
hospital stay.
 Urinary tract infection, respiratory tract infection and soft
tissue infection are common infections with increased
incidence in diabetes. Altered host defenses, vascular
abnormalities, frequent hospital admissions are
responsible for increased incidence.

3. RATIONALE OF THE STUDY
 Urinary tract being the prevalent infection site,
serious complications of urinary infection such as
emphysematous cystitis, pyelonephritis, renal or
perinephric abscess, bacteremia and renal papillary
necrosis occur more commonly in diabetic patients.
 Many urinary tract infections are asymptomatic and
whether the symptomatic urinary tract infections are
preceded by asymptomatic bacteriuria (ASB) is not
known.
 Hence it is of prime importance to study
Asymptomatic bacteriuria in type 2 diabetics
patients.

4. AIM OF THE STUDY
 To study the prevalence of Asymptomatic
Bacteriuria in type 2 diabetic patients.

5. OBJECTIVES
1. To find out the prevalence of Asymptomatic
Bacteriuria in type 2 diabetic patients.
2. To analyze the spectrum of organisms responsible
for Asymptomatic Bacteriuria in this group and its
antimicrobial sensitivity pattern.
3. To find the association of Asymptomatic Bacteriuria
with patient status (age, duration of diabetes,
complications, etc).
4. To find the association of Asymptomatic Bacteriuria
with glycemic level

6. METHODOLOGY
DESIGN : Cross-sectional study
STUDY SETTING: Outpatient department of general
medicine, Sree Balaji Medical College And Hospital,
Chrompet.
PERIOD OF STUDY : 3 years
SAMPLE SIZE: 200 type 2 diabetic patients

7. SAMPLE SIZE CALCULATION:

8. INCLUSION CRITERIA
Adult men and women with type 2 diabetes
mellitus who give voluntary consent were
included.

9. EXCLUSION CRITERIA
Those who had one or combination of the following were
excluded.
1. Symptoms of UTI - including dysuria, frequency, urgency,
abdominal discomfort, fever etc.
2. Vulvovaginitis
3. Pregnancy
4. Recent hospitalisation or surgery (<4 months)
5. Known urinary tract abnormalities (including cystopathy,
etc.)
6. Recent urinary tract instrumentation (catheterisation, etc.)
7. Culture positive for three or more organisms, funguria
8. Use of antimicrobials in the last 14 days
9. Past history of UTI

10. METHODOLOGY - CONSENT
An informed consent would be obtained from
participants.

11. METHODOLOGY
Selection of study subjects
Men and women with type 2 diabetes would be
recruited randomly from the general medicine
outpatient department

12. METHODOLOGY
• All study subjects would be interviewed during the first
visit of the study and their medical history including
age, duration of diabetes, medications, complications of
diabetes would be obtained.
Blood samples
• The following laboratory data would be included:
fasting and postprandial plasma glucose, HbA1C.
Urinary samples
• Each individual would be explained on the technique of
urine collection - midstream clean voiding urine
specimen collected in a wide mouthed sterile container
for the evaluation of bacteriuria.
• All urine samples would be immediately sent for urine
routine and culture.

13. METHODOLOGY
Urinary samples
Each individual would be explained on the technique of
urine collection - midstream clean voiding urine
specimen collected in a wide mouthed sterile container
for the evaluation of bacteriuria.
All urine samples would be immediately sent for urine
routine and culture.

14. DEFINITIONS
Diabetes mellitus
According to the American Diabetes Association
Criteria, a fasting plasma glucose concentration of ≥7.0
mmol/L, a 2 hour (post glucose) plasma glucose
concentration of ≥ 11.1 mmol/L or the use of glucose
lowering medications (oral agents or insulin)

15. DEFINITIONS
Asymptomatic bacteriuria
Asymptomatic bacteriuria is defined as the presence of atleast 10⁵
colony forming units/ml of 1 or 2 bacterial species in clear voided
midstream urine sample from an individual without symptoms of
urinary tract infection.
Presence of atleast 3 microorganisms in one urine specimen was
considered as contaminated urine and these specimens would be
excluded.
Cultures positive for Candida species would not be considered as
positive because this study was confined to bacteriuria.

16. STATISTICAL ANALYSIS
Descriptive statistics would be used for prevalence.
Chi-Squared test would be used to study association for
categorical variables and t test to compare continuous variables.
P value of <0.05 would be considered significant.

17. PARTICIPANTS IN THE STUDY:
The Investigator (Self)
Participants who take part in the study

18. ETHICAL CONSIDERATIONS
DOES THE STUDY INCLUDE HUMAN SUBJECTS OR ANIMALS?
Human subjects: - YES.
Animals: - NO
ARE PATIENTS INVOLVED IN THIS STUDY?
Yes
ARE STUDENTS SUBJECTS OF THIS STUDY?
No
WHAT IS THE SAMPLE SIZE REQUIRED FOR THIS STUDY? 200
IS THE PROCEDURE INVASIVE? GIVE DETAILS ABOUT THE BIOLOGICAL
SAMPLES.
Yes, the procedure is invasive. Blood samples for laboratory analysis will be collected.
RISKS OF THE PROCEDURE INVOLVED?
Nil
WILL THE SUBJECTS BE INVOLVED IN ANY OTHER EXPERIMENTATION DURING
THE STUDY?
No
PERSONAL EXPERIENCE OF THE INVESTIGATOR WITH THE PROPOSED
TECHNIQUE
Yes
DETAILS OF INFORMED CONSENT APPENDED (IN LOCAL LANGUAGE) ?
Standard written informed consent of the patient or patient's relative for participating in the study and for
collection of Biological Samples will be taken.
REMUNERATIONS TO THE SUBJECTS
Nil

19. REFERENCE
1. Bonadio M et al. Asymptomatic bacteriuria in women with
diabetes : influence of metabolic control. Clinical Infectious
Diseases 2004; 38 : e41-e45.
2. Geerlings SE et al. Asymptomatic bacteriuria may be considered a
complication in women with diabetes. Diabetes Care 23 : 744-
749, 2000.
3. Gratacos et al. Screening and treatment of asymptomatic
bacteriuria in pregnancy prevent pyelonephritis. J Infect Dis 169:
1390, 1994.
4. Keane EM et al. Prevalence of asymptomatic bacteriuria in
subjects with NDDM in San Luis Valley of Colorado. Diabetes
Care, Vol. 11, Issue 9708-712.
5. Kelestimur F et al. Asymptomatic bacteriuria in patients with
diabetes mellitus. Mikrobiyol Bull 1990;24:12632.

20. THANK YOU