RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the Candidateand Address
(in block letters) / Dr. DUBE SHAILESH KUMAR PRAMOD KUMAR
S/O Mr. P.S. DUBE
# 73, MAYUR PARK, NEW BAPU NAGAR,
AHMEDABAD – 380024.
GUJARAT.
2. / Name of the Institution / J.J.M. MEDICAL COLLEGE,
DAVANGERE - 577 004. KARNATAKA
3. / Course of study and subject / MEDICAL – POSTGRADUATE DEGREE
M.D. IN GENERAL MEDICINE
4. / Date of Admission to course / 28-05-2013
5. / Title of the Topic / “A STUDY OF URINARY TRACT INFECTION IN DIABETES MELLITUS”
6. / Brief Resume of the intended work :
6.1 Need for the study :
Diabetes mellitus is a syndrome characterized by chronic hyperglycemia and disturbance of carbohydrate, fat, and protein metabolism associated with absolute or relative deficiencies in insulin secretion and or insulin action.1
The world today is witnessing an epidemic of diabetes mellitus. Globally and nationally, diabetes mellitus with its complications has become the most important contemporary and challenging health problem. The prevalence in India is currently reported to be 20.0% in urban and 11.0% in rural population and by 2030 it is estimated that approximately 101.2 million Indians will be diabetic.2
Urinary tract is the most common site for infection in diabetics. Most urinary tract infections in diabetics are relatively asymptomatic. Many different micro-organisms can infect the urinary tract, but by far the most common agents are gram negative bacilli.4 Urine culture is the most useful means for diagnosing the presence of urinary tract infection and for identifying causative pathogens.3,4 With the help of urine culture results, we can institute appropriate antibiotic treatment, and prevent further complications.5
Hence the objective of the study is to determine the clinical characteristics, causative organisms, and anti-microbial susceptibility of pathogens in urinary tract infection in diabetes mellitus.
6.2 Review of literature :
Historical aspects:
The earliest written record of diabetes dates back to centuries before Christ. The Egyptian Papyrus Ebers (1500 B.C.) described an illness associated with the passage of much urine. A good clinical description was given by Celsius (30 B.C. to AD 50). The name diabetes was introduced by another Roman physician Aretaeus of Cappadocia (AD 30- AD 90). He gave the first complete clinical description, describing it as "a melting down of the flesh and limbs into urine" (Diabetes= a siphone; Melitus= honey).6
The urinary tract is probably the most common site of infection in the diabetics. There is a five-fold increase in frequency of acute pyelonephritis in diabetics than non-diabetics. Although most urinary tract infections in diabetics are asymptomatic, the presence of diabetes predisposes to severe infections. Diabetes mellitus has a number of long term effects on the genitourinary system. These effects predispose to bacterial urinary tract infection in patients with diabetes mellitus. Bacteriuria is more common in diabetic women then in non-diabetic women because of a combination of host and local risk factors. Changes in host defence mechanisms, the presence of autonomic neuropathy involving urinary bladder and the presence of micro-vascular disease in the kidneys, may all play a role. When upper urinary tract infections occur in diabetic patients, are frequently complicated. The upper urinary tract is involved up to 80 percent of the urinary tract infections in diabetic patients. Many different microorganisms can infect the urinary tract, but by the most common organism are gram negative bacilli. E.coli causes approximately 80% of the acute infections. The incidence of bacteremia due to Enterobacteriaceae is also increased in diabetic patient presumably because of increased incidence of urinary tract infection.3,4
Other gram negative rods, especially Proteus, and Klebsiella and other occasionally Enterobacteriaceae account for smaller proportion of uncomplicated infections.
The empirical antibiotic therapy of patient with urinary tract infection should be guided by an accurate anamnesis evaluating not only for age and sex but also the presence of a bladder catheter at the moment of urine collection or a history of recent bladder catheterization and previous courses of antimicrobial drugs.7
6.3 Objectives of the study :
· To determine the clinical characteristics, causative organisms and anti-microbial susceptibility of causative organisms in urinary tract infection in diabetes mellitus.
7. / Material and Methods :
7.1 Source of data :
Minimum of 100 patients, both male and female, with diabetes mellitus and urinary tract infection presenting to out-patient department or getting admitted in Bapuji hospital and Chigateri government hospital attached to JJM medical college will be included in study. The selection was made according to certain criteria.
The criteria for selection of cases were:
1. All proved cases of diabetes mellitus i.e, fasting venous blood glucose more than 126mg% and post prandial venous blood glucose at 2 hours after meals, more than 180mg%.
2. Proved urinary tract infection i.e., symptomatic patient in whom a 'clean catch' midstream
7.2. Method of collection of data (including sampling procedure if any):
Clinical evaluation a detailed history and complete physical examination supported by the relevant investigations.
Routine urine analysis will be done for proteinuria, glycosuria, pyuria. For urine culture clean voided midstream urine sample will be collected and bacterial colonies will be identified by standard bacteriological and biochemical procedures. Infection will be diagnosed on the basis of positive culture results.
Inclusion criteria:
· Patient who is greater than age of 18 years.
· Patient who are diagnosed as having diabetes mellitus and urinary tract infection based on positive urine culture.
Exclusion criteria :
· Patients who are negative for urine culture growth even though they have clinical features suggestive of urinary tract infection.
Study design:
A cross sectional clinical study of 100 new cases of diagnosed Diabetes mellitus is undertaken to study causative organisms responsible for urinary tract infections with the help of urine culture and sensitivity.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes
1. Complete blood count
2. Random blood sugar
3. Fasting blood glucose level
4. Post prandial blood glucose level
5. Urine routine
6. Urine culture and sensitivity
7.4. Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8. / References :
1. Peter H. Bennet, joslin's. 13th edition chapter И definition, Diagnosis and classification of Diabetes mellitus and impaired glucose tolerance page 193.
2. A. Ramchandran, Ak Das API textbook of medicine 7th edition XVIII- Diachetrlo I. Basic consideration of diabetes mellitus page 1097
3. Ooi B.S., Chen.B., and you: prevalence and site of bacteriuria in DM. Pool Grad Med J 1974;50:497.
4. Young, KR & Calncy, C.F: Urinary tract infection complicating diabetes mellitus, Med Din Noth Am.39; 1665:1955.
5. American diabetes association 2003 position statement Diabetes care column 26, supplement1, January2003 page 21.
6. Marble, A in Joslien's Diabetes mellitus 12th edition. Lea & Febger, Marble A, Krall, LP, Bradely R F. Philadelphia (Edn.): 1985 .p.1.
7. Bonadio M, Meini M, Spitaleri P, Gigli C. 2001 “ Current microbiological and clinical aspects of urinary tract infections”. Eur Urol, 40(4): 439-44.
9. / Signature of candidate
10 / Remarks of the guide / It is a good clinical study for Indian scenario as Diabetes mellitus and its related urinary tract complications are quite common in our country.
11 / Name & Designation of (in block letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide (if any)
11.4 Signature
11.5 Head of the
Department
11.6 Signature / Dr. RAJEEV AGARWAL M.D.(MEDICINE), D.N.B. (Nephrology)
Professor,
Department of GENERAL MEDICINE,
J.J.M. Medical College,
DAVANGERE - 577 004.
Dr. S.N. VISHWAKUMAR M.D.
Professor and H.O.D.,
Department of GENERAL MEDICINE,
J.J.M. Medical College,
DAVANGERE - 577 004.
12 / Remarks of the
Chairman & Principal
12.2. Signature.
Approval of ethics committee
Dr. DUBE SHAILESH KUMAR PRAMOD KUMAR
POST GRADUATE STUDENT
DEPT. OF GENERAL MEDICINE
J.J.M MEDICAL COLLEGE
DAVANGERE-577004
KARNATAKA
The institutional ethics committee, J.J.M Medical College, Davangere has reviewed and discussed your application to conduct the study/dissertation entitled
TITLE: “A STUDY OF URINARY TRACT INFECTION IN DIABETES
MELLITUS”
The following documents were reviewed
1. Trail protocol(including protocol amendments), dated ______version no. (S) ______(not applicable)
2. Patient information sheet and informed consent form(including updates if any) in English and/or vernacular language.(yes) in vernacular language.
3. Investigator’s brochure, dated______,version no. _____(not applicable)
4. Proposed methods for patient accural including advertisement(s)etc. proposed to be used for the purpose(not applicable)
5. Principal investigator’s current CV
6. Insurance policy/compensation for participation and for serious adverse events occurring during the study participation (not application)
7. Investigators undertaking (appendix vii) ( not applicable)
We approved the study to be Conducted in its presented form.
The institutional ethics committee , J.J.M Medical college, Davangere expects to informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/informed consent and asks to be provided a copy of the final report.
Yours sincerely,
Member secretary, Ethics committee Chairman/ vice Chairman
Ethics Committee