Bangalore.
Annexure- II
Proforma For Registration Of Subjects For Dissertation
1. / NAME OF THE CANDIDATE AND ADDRESS
(IN BLOCK LETTERS) / DR.ROHIT N. MAIDUR
POST GRADUATE IN GENERAL MEDICINE,
KARNATAKA INSTITUTE OF
MEDICAL SCIENCES,
HUBLI-580022.
2. / NAME OF THE INSTITUTION / KARNATAKA INSTITUTE OF
MEDICAL SCIENCES,HUBLI-22.
3. / COURSE OF STUDY AND SUBJECT / M.D. IN GENERAL MEDICINE
4. / DATE OF ADMISSION TO COURSE / 28-04-2010
5. / TITLE OF THE TOPIC / “SPIROMETRIC EVALUATION IN PATIENTS WITH DIABETES MELLITUS”
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR STUDY:
Diabetes mellitus is a metabolic disorder characterized by hyperglycemia resulting from defects in insulin secretion, action or both. Diabetes is a multisystemdisorderthat affects many organs of the body. Studies have shown this metabolic disorder can present with micro-vascular pathologies leading to autonomic neuropathy, nephropathy, retinopathy and peripheral neuropathy, and macro-vascular pathologies leading to coronary artery disease, cerebrovascular accidents and peripheral vascular disease.If diabetes is detected early and adequate steps are taken, it may be possible to significantly delay the occurrence of complications and thereafter the progression.
There are histopathological changes seen in lungs ofdiabetic subjects such as thickening of alveolar epithelial and pulmonary capillary basal lamina leading to reduced pulmonary elastic recoil and lung volume6. Non-enzymatic glycoslyation induced alteration of lung connective tissue is the most likely mechanism underlying the mechanical pulmonary dysfunction in diabetic subjects. The above pathophysiological mechanisms suggest that lung is also involved in diabetic subjects as target organ6.
Pulmonary function tests are employed to access the functional capacity of lungs. Itincludes spirometry,body plethysmographyand helium dilution test. Functional residual capacity, Total lung capacity, Residual volume are measured by body plethysmography or dilution tests.Spirometry evaluatesthe integrated mechanical function of the lung, chest wall, and respiratory muscles by measuring the total volume of air exhaled from a full lung to an empty lung. Itis the most commonly employed pulmonary function testformeasuring lung function, specifically the measurement of the volume and flow of air that can be inhaled and exhaled. The parameters measured in spirometry are;
1.Vital Capacity(VC)
2.Forced Vital Capacity(FVC)
3.Forced Expiratory Volume(FEV) at intervals of 0.5,1.0 seconds
4. Forced Expiratory Flow 25-75%(FEF 25-75%)
5.Maximal Voluntary Ventilation(MVV)
Recent studies have focused on lung as target organ in diabetes with evaluation of pulmonary function tests.Present study is intended to find the spirometric changes in patients with diabetes mellitus.
6.2 REVIEW OF THE LITERATURE:
Berriche O.et al1 in the study titled “Is respiratory function altered in diabetes mellitus”published in 2009 evaluated respiratory function among diabetic patients with measurement of pulmonary function test concluded that effect of diabetes on respiratory function exists, but remains often sub-clinic because of the broad ventilatory reserve in human beings.
Yeh H. et al2 in “A cross sectional and prospective study of lung function in adults with type 2 diabetes mellitus ;the atherosclerosis risk in communities (ARIC) study” published in 2008 that was conducted to analyze diabetes status and lung function using baseline and 3 year follow –up data on 1,100 diabetic and 10,162 non-diabetic middle aged adults from atherosclerosis risk in communities(ARIC) study The study tested the hypothesis that diabetes was independently associated with reduced lung function and concluded that in cross-sectional analyses middle aged adults with type 2 diabetes mellitus had a significantly lower FEV1,FVC, compared to their non-diabetic counterparts and prospective analyses rapid decline in FVC in diabetes mellitus subjects than in their non-diabetic counterparts.
Wendy D.A. et al3 “Glycemic exposure is associated with reduced pulmonary function test in Type 2 diabetes”in this study 495 patients with Type-2 diabetes mellitus who had no history of pulmonary disease were studied between 1993 and 1994 by community based cohort study and 125 patients were restudied 7 years later for spirometric changes and were expressed as absolute terms or as percentage predicted for age, sex and heightshowed that there was a decrease in mean percentage predicted values of each spirometric measure in the whole cohort.Absolute measures continued to decline at an annual rate of 68ml, 71ml and 84ml/year and 17 l/min for forced vital capacity, forced expiratory volume 1, vital capacity and peak expiratory flow respectively in the study group.
Sreeja C.K. et al4in the study “Pulmonary function in patients with diabetes mellitus” the lung function tests were carried out in20 Type2Diabetes mellitus and 20 Type1 Diabetes mellitus subjects and 40 subjects as controls. There was a significant reduction in FEV1/FVC in both diabetes mellitus groups compared with controls as well as decrease in FEV1/FVC in both the groups was related to the poor mechanical properties of lung such as lung compliance and elastic recoil of lungs, total lung capacity was lower in diabetes mellitus group.
Walter.E.R. et al5 in the study” Association between glycemic state and lung function” conducted to analyze the relationship between fasting blood sugar and pulmonary function test by spirometric assessment in subjects with diabetes mellitus among 87 members of Framingham study found the deterioration in pulmonary functions as forced expiratory volume in first second, FVC & FEV1/FVC ratio, it was also found that higher levels of FBS were associated with lower pulmonary function the FVC was lower by 109 ml, forced expiratory volume in first second was lower by 27 ml and FEV1/FVC was higher by 1.5 in the diabetes mellitus subjects as compared to non diabetic subjects.
Sandler M. et al6 in study “Is lung a ‘target organ’ in diabetes mellitus”published in 1990 showed histopathological evidence of lung involvement in subjects with diabetes mellitus by thickening of alveolar epithelial and pulmonary capillary basal laminae suggestive of pulmonary microangiopathy and abnormal pulmonary function tests were detected in diabetic patients such as reduced lung volumes, reduced pulmonary elastic recoil in diabetes, impaired diffusion due to a reduced pulmonary capillary blood volume and non-enzymatic glycosylation induced alteration in the lung connective tissue was suggested to be the most likely pathogenic mechanism underlying the mechanical pulmonary dysfunction in diabetic subjects.
Lange P.et al7in the study “The possible association between diabetes mellitus, plasma glucose, forced vital capacity and forced expiratory volume in 1 second” in 11,763 subjects above 20yrs. where 284 of the participants were with diabetes mellitus and showed slight impairment of pulmonary function tests ,it was more prominent in subjects treated with insulin than those taking oral hypoglycemic agents, FVC was reduced by 334ml and forced expiratory volume
in first second by 239ml in subjects treated with insulin and FVC was reduced by 184ml and forced expiratory volume in first second by 117ml in subjects treated with oral hypoglycemic agents as compared to controls.
6.3 AIMS AND OBJECTIVES OF THE STUDY:
- To study the pattern of spirometric changes in diabetes mellitus
- To correlate spirometric changes with
- Type of diabetes mellitus
- Duration of diabetes mellitus
- Glycemic status
7. / MATERIALS AND METHODS :
7.1 SOURCE OF DATA:
Patientsvisiting medicine OPD and patients admittedat IPD of KIMS Hospital, Hubli,during the period of 1st January 2011 to31st December 2011 will be taken for study considering the inclusion and exclusion criteria.
7.2 METHODS OF COLLECTION OF DATA:
Information will be collected through a pre tested and structured proforma for each patient.
Qualifying patients will be undergoing detailed history, clinical examination, routine investigations and spirometric evaluation.
TYPE OF STUDY:
Single centrecross sectional hospital based time bound study.
INCLUSION CRITERIA
All patients presenting to OPD and and patients from IPD at KIMS Hospital Hubli,who are proved cases of type 2diabetes mellitusor type 1 diabetes mellitus.
EXCLUSION CRITERIA:
- Smokers
- Previous history of lung disease
- Signs and symptoms of respiratory infections at the time of test
- History of being admitted during past six months with respiratory symptoms
- History of cardiovascular illness
After applying inclusion and exclusion criteria a randomly selected group of patients will undergo detailed history, clinical examination and following set of investigations,
Complete blood counts
Blood urea
Serum creatinine
Fasting blood sugar
Post-prandial blood sugar,
HbA1c
X ray chest (PA view)
Spirometry.
SAMPLE SIZE:
The minimum number of patients required to obtain significant results will be taken up for the study among those visiting OPD and from IPD of KIMS,Hubliafter applying inclusion and exclusion criteria.
STATISTICAL ANALYSIS
The data will be analyzed with appropriate statistical method.
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,
Complete blood counts
Blood urea
Serum creatinine
Fasting blood sugar
Post-prandial blood sugar
HbA1c
Chest X ray (PA view)
Spirometry
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of 7.3?
Yes, ethical clearance has been obtained from the ethical committee KIMS, Hubli.
8. / LIST OF REFERENCES:
- Berriche O, Ben Mami F, Mhiri S, Achour A. Is the respiratory function altered during diabetes mellitus? Service C de Diabétologie et Nutrition- Institut National de Nutrition 2009 Aug; 87(8):499-504.
- Hsin-Chieh Yeh,Naresh M. Punjabi,Nae-Yuh Wang,James S.Pankow,Bruce B.Dunkan,Christopher E.Cox,Elizabeth Selvin,Fredrick L.Brancati.Cross-Sectional and prospective study of lung function in adults with type 2 diabetes mellitus:The Atherosclerosis Risk in Communities[ARIC] Study. Diabetes Care.2008 April; 31[4]:741-746.
- Davis A. Wendy, Matthew Knuiman, Peter Kendell, Valerie Grange, Timothy M.E.Davis.Glycemic Exposure is Associated with Reduced Pulmonary Function in Type-2 Diabetes.Diabetes care 2004:27:752-757.
- Sreeja C.K, Elizabeth Samuel, C.Kesava Chandra, Shankar Shashidaran. Pulmonary function in patients with diabetes mellitus. IJPP 2003; 47(1): 87-93.
- Walter.E.Robert, Alexa Beiser, Rachel J, Givelber, George T, O’Connor, et al. Association between glycemic state and lung function. Am J Respir Crit Care Med 2003; 167:911-916.
- Sandler Malcom.Is the Lung a ‘Target Organ’ in Diabetes Mellitus. Arch Intern Med.1990; 150:1385-1388.
- Lange P.Diabetes mellitus, plasma glucose and lung function in a cross sectional population study.Eur Respir J 1989:2:14-19.
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE
11. / 11.1NAME AND DESIGNATION OF
GUIDE / DR.ANAND KOPPAD
ASSOCIATE PROFESSOR
DEPARTMENT OF MEDICINE
KIMS,HUBLI
11.2 SIGNATURE
11.3 CO-GUIDE / DR. SHAILENDRA D.S.
ASSOCIATE PROFESSOR
DEPARTMENT OF TUBERCULOSIS AND CHEST DISEASES
KIMS, HUBLI.
11.4 SIGNATURE
11.5 HEAD OF THE DEPARTMENT / DR. H. MALLIKARJUN SWAMY.
PROFESSOR AND HEAD,
DEPARTMENT OF MEDICINE
KIMS, HUBLI.
11.6 SIGNATURE
12. / 12.1 REMARKS OF THE PRINCIPAL AND CHAIRMAN
12.2 SIGNATURE