IntroductionDiabetes population is relentlessly increasing. This rise is substantially contributed by increasing prevalence in rural communities. We need to have prevalence studies in different communities to know the nature of the disease. For conducting diabetes prevalence studies, best test to rely upon is OGTT. This study was aimed to examine the feasibility of conducting OGTT in a rural community as a diagnostic tool in diabetes prevalence study.MethodsMeeting village leaders, arranging community gatherings and involving village representatives in health awareness program were the preparatory methods used in the study. Study team was trained to carry out various procedures involved. Every alternate person according to the electoral list was identified and reminded about his turn by repeated community announcements and meeting personally. Brief history, anthropometries were taken and OGTT was performed with 75 gram glucose load.ResultsÃ‚Â Out of 341 participants invited, 326 consented and 318 completed the study. Eight participants did not turn up for second blood test but under went all other procedures. We conducted ten screening visits to complete the entire study procedures. The response rate for consenting and entering the study was 95.6% and that for completing the study was 93.2%. Out of 318 participants completed the study, 182 (57.2%) were females and 136 (42.7%) males. So total time spent for 10 screening visits was 70 hours. Total cost of the screening the village was 20,520 Indian rupees.ConclusionThe present study suggests that collecting OGTTs in rural communities is feasible. Committed research team, proper heath education, active involvement of the community members and long term association before starting the screening procedures results in better response rates

Somannavar2, Ramesh Araganji3, Jayaprakash Appajigol1*, Manjunath

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Recent Research in Science and Technology 2011, 3(9): 53-56 ISSN: 2076-5061 www.scholarjournals.org   www.recent-science.com 53  RRST-General Medicine Feasibility of Oral Glucose Tolerance Test as a Diagnostic Tool for Diabetes Prevalence Study in a Rural Community Jayaprakash Appajigol1*, Manjunath Somannavar2, Ramesh Araganji3 1Department of General Medicine, KLE University’s Jawaharlal Nehru Medical College,Nehru nagar, Belgaum-590 010, Karnataka, India 2Department of Biochemistry, KLE University’s Jawaharlal Nehru Medical College, Nehru nagar, Belgaum-590 010, Karnataka, India. 3Department of Physiology, Bangalore Medical College, Bangalore, Karnataka, India Article Info  Abstract Article History  Introduction Diabetes population is relentlessly increasing. This rise is substantially contributed by increasing prevalence in rural communities. We need to have prevalence studies in different communities to know the nature of the disease. For conducting diabetes prevalence studies, best test to rely upon is OGTT. This study was aimed to examine the feasibility of conducting OGTT in a rural community as a diagnostic tool in diabetes prevalence study. Methods Meeting village leaders, arranging community gatherings and involving village representatives in health awareness program were the preparatory methods used in the study. Study team was trained to carry out various procedures involved. Every alternate person according to the electoral list was identified and reminded about his turn by repeated community announcements and meeting personally. Brief history, anthropometries were taken and OGTT was performed with 75 gram glucose load. Results  Out of 341 participants invited, 326 consented and 318 completed the study. Eight participants did not turn up for second blood test but under went all other procedures. We conducted ten screening visits to complete the entire study procedures. The response rate for consenting and entering the study was 95.6% and that for completing the study was 93.2%. Out of 318 participants completed the study, 182 (57.2%) were females and 136 (42.7%) males. So total time spent for 10 screening visits was 70 hours. Total cost of the screening the village was 20,520 Indian rupees. Conclusion The present study suggests that collecting OGTTs in rural communities is feasible. Committed research team, proper heath education, active involvement of the community members and long term association before starting the screening procedures results in better response rates.  Received : 27-05-2011  Revised : 25-07-2011  Accepted : 04-08-2011  *Corresponding Author  Tel : +919790196151       Email:  jayaprakashappajigol@gmail.com   ©ScholarJournals, SSR  Key Words: Diabetes, Feasibility, Oral Glucose Tolerance Test, Rural Community    Introduction India is currently the epicenter of the diabetes epidemic with a prevalence of 41 million in 2006 that will increase to 70 million by the year 2025.1 The increased disease burden in rural areas is a significant contributor to the epidemic. Traditionally type 2 diabetes mellitus (T2DM) had a low prevalence in rural (1.3%) compared to urban (3%) communities because of active life-styles.2 However, economic growth, better agricultural equipment, urbanization of villages and changing dietary patterns have had effect on the prevalence of diabetes in rural communities also.3 However, as India is a country with diverse cultures and life styles, so the burden of disease also varies in different populations4, 5, 6. Diabetes prevalence studies are required in different population groups across the country to determine the exact nature of disease. Results from such studies is extremely important to the government of India which has recently launched the National Program for control of Diabetes, Cardiovascular Disease and Stroke.7 However, a reliable and feasible screening method to conduct the diabetes prevalence studies that can provide this data is not yet available to researchers.  Need for the OGTT Urine glucose testing was used in studies conducted in the 1930s8, but has been more discounted because of low sensitivity.9,1O Fasting plasma glucose (FPG) tests are problematic as the sole diagnostic test because of low sensitivity, that is, one out of three cases of diabetes will be missed. FPG also cannot identify participants with impaired glucose tolerance (IGT)11. It has been documented that many Jayaprakash Appajigol et al./Rec Res Sci Tech 3 (2011) 53-56     54Asians with diabetes are known to have isolated hyperglycemia 2 hr post glucose loading with normal fasting values, hence only FPG is not reliable.12 HbA1c would be useful when used as part of a stepwise process, for example combined with FPG13 but is not feasible in India because of poor standardization and the high cost associated with it. Random blood glucose is usually not used because of its variability and poor sensitivity.14 Given, these limitations, the oral glucose tolerance test (OGTT) appears to be the best available test to detect the prevalence of T2DM in countries like India.  However, challenges faced in conducting prevalence studies with the OGTT are due to complexity of the procedures, such as  multiple timed blood samplings and consumption of 75 gram glucose drink,  resulting in low response rates. This is especially true in rural communities where people go to fields early in the morning hours and come back only in the late evening. Economic and survival concerns predominate except when illness becomes symptomatic. Although implementation may be challenging, the results provide a precise estimate of glycemic states.  We have limited data explaining the methods employed, challenges faced and strategies implemented to get good response rate in conducting OGTT in rural community. So pilot testing will help to analyze the difficulties and in developing strategies to overcome.   This study was aimed to examine the feasibility of conducting OGTT in a rural community as a diagnostic tool in diabetes prevalence study. Materials and methods This was a cross sectional study to evaluate the feasibility of conducting OGTT in rural community as a tool for diabetes prevalence study. Population The village Jakanaykana koppa, 22 Km away from our Medical College was selected due to the feasibility and minimal influence of urbanization on the village. The population of the village was around 950. Electoral list had 682 people in it.  We planned to screen every alternative person according to the list and if the person denies to consent or not eligible for the study based on inclusion/exclusion criteria, the very next person was included. Ethics committee of Jawaharlal Nehru Medical College Belgaum approved the protocol. Analysis Considering prevalence of T2DM (p) as 10% and absolute error of 2.5%, sample size estimated to be 580. Revising sample size for finite population, we got the sample size of 315. Data collected was entered on a excel sheet and response rate was calculated for every 100 participants by simple counting. Procedures Meeting the village leaders: We went to the door step of village leaders and explained about increasing burden of non-communicable diseases in rural communities. They responded positively by citing the example of recent observation of rise in death due to heart attack in their village, which was the first victory we got in establishing a good rapport in the village. Based on this we explained the possible causes and risk factors for rise in rate of heart attacks and how the science is advancing to prevent these deaths. Leaders got excited by knowing the facts. Then we explained about our study and advantages and disadvantages of participation. We also explained them clearly that the participation in the study is going to be strictly on voluntary bases.  Arranging community gathering: A community gathering was planned on a specific day along with village leaders to disseminate knowledge about non-communicable diseases and T2DM. The request to attend the gathering was disseminated by the way of person to person spreading the news, distributing flyers, repeated announcements through the community announcement speakers and street to street announcement by a villager who is a designated person in the village. Involving villagers in health awareness programs: With the help of above mentioned methods about 100 villagers gathered at the specified place. Village leaders spoke about the rising burden of non-communicable diseases in rural communities and importance of early detection and timely treatment of T2DM to prevent its complications. Research team members introduced the study to the community. We explained about the methods of each component of our study including history taking, anthropometry, blood pressure recording, the procedure of OGTT and informing the results and further plan of treatment. Involving villagers to speak to their own people was critical, as it became an important motivation to participate in the study.  Training the study team: We trained study staff for filling up of the data forms, taking anthropometric measurements, collection of blood samples and administration of 75 grams of glucose. We developed a standard operating procedure (SOP) for the various steps to be followed by the study team once participant enters the site as follows. Every screening visit was planned on Sundays. At each screening visit 40 participants were invited to participate. Each participant was informed about the date of screening a week prior personally meeting by a village volunteer. Every day reminders were sent on last three days before the day of screening by village announcement methods. Once participant came to the study site the standard steps as described were followed. Step 1 Informed consent was taken and participant enrolled according to inclusion and exclusion criteria. Step 2 Demographic data namely, name, age, sex, occupation, years of residence the village, Medical history consisting of history of concomitant medications, history of pregnancy in case of females, history of T2DM, hypertension, ischemic heart disease, habits of tobacco and alcohol consumption. Step 3 Anthropometric measures, including, Weight measurement in Kg, Height in meters, BMI=Wt(Kg)/(Ht)2 (m), waist measurement in centimeters. Blood pressure measurements 3 times at least 5 minutes apart in sitting posture by using mercury sphygmomanometer. Step 4 Biochemical tests-Fasting blood sample was collected after overnight fasting for 8-10 hours. Participants were asked to drink 75 gram glucose in water in 5 minutes and Jayaprakash Appajigol et al./Rec Res Sci Tech 3 (2011) 53-56     55second blood sample was collected after 2 hours. (Those who were known diabetes patients were not given oral glucose, instead asked to have light breakfast 2 hours before the second blood drawing). Blood glucose testing was  done by glucose oxidase-peroxidase (GOD-POD) method. Any participant who had not maintained fasting or postprandial state satisfactorily was screened in the next visit. At each visits we collected field notes and journals to document the daily flow and challenges that occurred in implementing this study. Then we analyzed them at the end of each visit and strategies were developed to overcome the same in subsequent visits.    Protection of Human Subjects The approval of institutional ethics committee was taken before the start of the study. All participants signed the informed consent form before the study. All the patient information kept confidential. Results  Out of 341 participants we invited 326 consented and 318 completed the study. Eight participants did not turn up for second blood test but under went all other procedures. We conducted ten screening visits to complete the entire study procedures.  Response rate  The response rate for consenting and entering the study was 95.6% and that for completing the study was 93.2%. Out of 318 participants completed the study, 182 (57.2%) were females and 136 (42.7%) males.  The following table shows number of participants screened at each screening visit.  Table-1: Number of participants screened at each screening visit     Time required  Each screening visit screened an average of 33 participants and lasted for 5 hours i.e. from 6:00 AM to 11:00 AM. Travel time required for each screening visit was 2 hour. So total time spent for 10 screening visits was 70 hours.  Cost of the screening program   Each blood test cost was 25 Indian rupees and total cost for blood test of 326 participants was 16100  rupees. Travel expenses included, expenses for ten village visits for screening and 5 pre-screening visits to village. It accounted for 3420 rupees. The cost of data forms, consent forms and flyers was 1000 rupees. Workers in study team and community members worked on voluntary basis. So total cost of the screening the village was 20520 Indian rupees (461 US dollars approximately). Challenges faced and the strategies developed to overcome  Field notes documenting the challenges encountered while implementing the screening was analyzed and following strategy were developed. Reluctance for blood testing: Many villagers never wanted to know about a disease which is asymptomatic and not hampering their work. Discussing the importance of early detection and possibility of prevention of T2DM made them to participate.  False propaganda: During our third screening visit we came to know that there was a false propaganda in the village that we utilize the villagers’ blood for our hospital purpose. It was reflected by very low turnout for screening i.e. 21during that screening visit. Village leaders came to our rescue and with their help we could convince the truth and subsequent screening visits response was good. Discussion  Previous prevalence studies using different methodologies have reported different response rates as below. Prevalence study by Ramachandra et al15 in rural Chennai in 2004 had response rate of 75.4% where OGTT with venous blood testing was used as a diagnostic tool. The non-responders in the study refused to undergo any medical screening or were not available at the time that tests were conducted. It appears that developing good rapport with the community and proper health education made many participants to undergo screening. And we started screening early in the morning i.e. at 6:00 AM, so that the availability of villagers was taken care. Screening Visit           Number of        participants screened Visit 1 38 Visit 2 43 Visit 3 21 Visit 4 34 Visit 5 27 Visit 6 36 Visit 7 28 Visit 8 32 Visit 9 36 Visit 10 31 Jayaprakash Appajigol et al./Rec Res Sci Tech 3 (2011) 53-56     56 Another study by Sadikot et al5 in 2004 got a response rate of 91.2 in rural arm of the study but OGTT was conducted using capillary blood. In this study we used OGTT with venous blood sampling which is according to the WHO guidelines. Vijaykumar et al16, in prevalence study in rural Kerala with only fasting plasma glucose got a response rate of 82.7% and they further concluded that carrying out OGTT requires greater resource in terms of money and time. In our study, we could get a better response rate with minimal resources.    Motivation of rural community to participate in diabetes prevalence studies is a difficult task due the commitment they have in the fields. By following an organized and structured method we achieved good response rate of 93.2%.  Strengths and limitations  This was a small study yet had the advantage of being a population based in a rural community which had minimal influence of urbanization and majority of participants never knew about the T2DM. We used OGTT with venous blood sampling which is more authenticated method for diagnosing T2DM. It demonstrated that the involvement of community members played an important role for the success of the study. This study effectively utilized village communication media like loud speaker announcements and street announcements which are cost effective and reach everyone in villages.  Conclusions The present study suggests that collecting OGTTs in rural communities is feasible. Committed research team, proper heath education, active involvement of the community members and long term association before starting the screening procedures results in better response rates.  Acknowledgements We express profound sense of gratitude to  each member of research team who struggled hard voluntarily to complete the study. We are grateful to Prof. Mallupur, statistician, J.N. Medicla College, Belgaum for his contribution. We thank all the villagers of Jakanayakanakoppa for their whole hearted participation. References [1] Sicree R, Shaw J, Zimmet P. Diabetes and impaired glucose tolerance. In: Gan D, editor. Diabetes     Atlas. International Diabetes Federation. 3rd ed. Belgium: International Diabetes Federation;  2006 p. 15-103. [2] Gupta OP, Joshi MH, Dave Sk. Prevalence of diabetes in India. Advances in Metabolic Disorders 1978;9:147-165. [3] Fall CH. Non-industrialised countries and affluence. British Medical Bulletin 2001; 60:33-50 [4] Chow CK, Raju PK, Raju R et al. The prevalence and management of diabetes in rural India. Diabetes Care 2006;29:1717-18. [5] Sadikot SM, Nigam A, Das S et al. The burden of diabetes and impaired glucose tolerance in India using the WHO 1999 criteria: prevalence of diabetes in India study (PODIS). Diabetes Research and Clinical Practice 2004;66:301-07 [6] Zargar AH, Khan AK, Masoodi SR et al. Prevalence of type 2 diabetes mellitus and impaired glucose tolerance in the Kashmir Valley of the Indian subcontinent. Diabetes Research and Clinical Practice 2000;47:135-46. [7] http://www.diabetesmoz.com/2008/01/ accessed on February 18, 2008. [8] Chakravarthy A: A study of diabetes and its treatment with special reference to Bengalees and their diet. Indan Medical Record 1938; 58:65. [9] Engelgau MM, Narayan KM, Herman WH. Screening for type 2 diabetes. Diabetes Care 2000; 23:1563–80. [10] Borch-Johnsen K, Lauritzen T, Glumer C, Sandbaek A. Screening for type 2 diabetes – should it be now? Diabetic Medicine 2003;20:175–81. [11] N Waugh, G Scotland, P McNamee et al. Screening for type 2 diabetes: literature review and economic modeling 2007; Vol. 11: No. 17:22 [12] Qiao Q, Nakagami T, Tuomilehto J, et al. Comparison of the fasting and the 2-h glucose criteria for diabetes in different Asian cohorts. Diabetologia 2000;43: 1470-5. [13] Borch-Johnsen K, Lauritzen T, Glumer C, Sandbaek A. Screening for type 2 diabetes – should it be now? Diabetic Medicine 2003;20:175–81. [14] Qiao Q, Keinanen-Kiukaanniemi S, Rajala U, Uusimaki A, Kivela SL. Random capillary whole blood glucose test as a screening test for diabetes mellitus in a middle-aged population. Scandinavian Journal of Clinical and Laboratory Investigation 1995;55:3–8. [15] Ramachandran, C. Snehalatha, A. D. S. Baskar;Temporal changes in prevalence of diabetes and impaired glucose tolerance associated with lifestyle transition occurring in the rural population in India. Diabetologia (2004) 47:860–865 [16] Vijayakumar G, Arun R, Kutty VR;High prevalence of type 2 diabetes mellitus and other metabolic disorders in rural Central Kerala.The Journal of the Association of Physicians of India. 2009 Aug; 57:563-7.    

Feasibility of Oral Glucose Tolerance Test as a Diagnostic Tool for Diabetes Prevalence Study in a Rural Community

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Feasibility of Oral Glucose Tolerance Test as a Diagnostic Tool for Diabetes Prevalence Study in a Rural Community

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