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Mumbai, November 11, 2014 – Bayer Zydus Pharma, in collaboration with Prof Dr. Shashank Joshi (Padma Shri awardee and President of Association of Physicians of India) and nine other imminent endocrinologists/diabetologists, conducted the STARCH study across five regions in India – North, South, East, West and Central India. STARCH stands for Study To Assess the dietaRy CarboHydrate content of Indian type-2 diabetes population. The study was conducted with the objective to assess the total and complex carbohydrate content in the daily diet of the diabetes population. Dr. Joshi was the Lead Investigator for this study.
Data from the STARCH study has also been published online in the international medical journal, BMJ Open. The analysis clearly shows that the Indian diabetes population consumes higher than recommended carbohydrates in their diet (64.1% energy comes from carbohydrates).
Bayer Zydus Pharma will operate in key segments of the Indian pharmaceuticals market with a focus on: women’s healthcare, metabolic disorders, diagnostic imaging, cardiovascular diseases, anti-diabetic treatments and oncology. In addition to Bayer HealthCare’s currently existing pharmaceutical product portfolio in India, the Joint Venture is also intended to focus on the sales and marketing of future patented pipeline pharmaceutical products. Both Bayer HealthCare and Zydus will supply the Joint Venture with products sourced from its manufacturing operations at existing locations.
India has the 2nd largest diabetes population with an estimate of 65 million affected people, as of 2013. This is projected to rise to 109 million by 2035 according to the International Diabetes Federation. Diet and dietary carbohydrates have a direct impact on blood glucose control (especially the post-meal blood glucose) in diabetes patients. All national and international guidelines suggest diet management as the initial mainstay for the management of diabetes. Barring a few studies, there has been no study documenting the dietary habits of the diabetes population compare to non-diabetes population across India. There was a need to conduct a dietary survey considering the diverse food habits in various parts of the country.
“Diabetes is emerging as a major health issue for India. Through the STARCH study we hope to provide medical professionals valuable insights on the carbohydrate consumption patterns across India and its impact on diabetes management. The STARCH study is our endeavor to improve the life of our patients and is in line with our mission at Bayer – Science for a Better Life” says Angel - Michael Evangelista, Managing Director – Bayer Zydus Pharma
The STARCH Study provides information on the dietary carbohydrate, fat and protein contribution in food consumed by diabetes participants and also shows how it compares with non-diabetes participants across India.
The study enrolled 796 participants, from March 2012 to September 2012, from 10 sites across all regions of India. The participants enrolled in the study were divided in two groups - a) diabetes group and b) Non – diabetes group. In the study, the diabetes population was matched with the non-diabetes population with respect to age, sex, and site. Participants who were 18 years and above, of either sex and diagnosed with diabetes for atleast 12 months, were eligible in the diabetes group. A 3-day dietary recall (2-typical days in the week plus 1-Sunday) data was used to analyze the dietary findings in this study.
According to Dr. Shashank Joshi “The STARCH study highlights the fact that carbohydrates are consumed widely across India and not only in South of India.This is contrary to the myth that people in the Southern part of the country consume higher carbohydrates in their meals. Even if diabetes participants know that they have diabetes and need to follow certain diet patterns, they do not necessarily adhere to it.” In the diabetes group, the mean percentage of total energy intake from carbohydrates was 64.1%, which is much higher than the upper limit of 60% as recommended by the National Institute of Nutrition. High carbohydrate consumption amongst people with diabetes is associated with abnormal blood sugar levels, particularly the post-meal blood sugar levels (table 1).
Table 1: Glycemic level after stratification by percent energy from carbohydrateconsumption in T2DM group (descriptive observation).
Region wise data showed that carbohydrate consumption is more than recommended at 60% across all 5-zones, with the highest being reported in central India (67.2%) (Figure 1)
The study also assessed the blood glucose control in diabetes participants and observed that only 33.1% have blood glucose within recommended levels (i.e. HbA1c <7%). Further, there was clear non-adherence (only 38.1%) to the diet plan advised by their physician/dietician.
The authors suggested that people with diabetes should be encouraged to achieve optimal metabolic control through a balance of food intake, physical activity and medication considering these observations to avoid long-term complications.
Dr. Satinath Mukhopadhyay, Professor, Department of Endocrinology, IPGME&R and SSKM Hospital, Kolkata, also one of the investigatorsof the study says, “The STARCH study is an eye opener as far as the widely varying dietary habits of persons with diabetes in different parts of the country is concerned. A 'one size fits all' approach to medical nutrition therapy is unlikely to succeed in India.”
Prof. Dr. Anil Bhansali, Professor & Head, Department of Endocrinology, PGIME&R Chandigarh & Chairman Organizing Secretory ESICON 2014, investigator from North India says “The STARCH study substantiates our belief about carbohydrates consumption. A startling observation in our study was that our patient consumes “good” carbohydrates and reasonable amount of proteins. By this observation, anti-diabetes drugs which target dietary carbohydrates may be the first choice to treat patients.”
In conclusion to the study results, Dr. Joshi says, “As clinicians, we need to ensure that the patients are provided with proper diet counselling with support from a dietician if required.”
About the STARCH study:
STARCH (Study To Assess the dietaRy CarboHydrate content of Indian diabetic population) was an exploratory cross-sectional, single visit, two-arm, multicentre, epidemiological survey designed to assess the dietary carbohydrate content of Indian diabetes and non-diabetes population.
The study was conducted at 10 centres across India ensuring population from all zones considering different dietary patterns viz. west (Mumbai & Ahmedabad), east (Kolkata & Agartala), north (Chandigarh & Allahabad), south (Bangalore & Hyderabad) and central India (Indore & Bhopal) comprehended between March 2012 and September 2012.
A total of 796 participants were enrolled in the study; of those, two were screen failures and the remaining 794 participants (385 in the diabetes group and 409 in thenon-diabetes group) completed the survey. Region-wise recruitment was: north region (n=160), east region (n=180), south region (n=158), west region (n=116), and central India (n=180). Participants were enrolled from endocrinology/diabetology clinics/hospitals with clinical research facilities during routine outpatient visits.
Participants aged =18 years of either sex, diagnosed with diabetes for at least 12 months, were eligible in the diabetes group, whereas participants not on any diet plan or dietary advice and who visited for acute illnesses/conditions that do not affect inclusion in the survey were included in the non-diabetes group.For each participant, demographics, medical & treatment history, 3-day dietary recall to assess dietary contents & blood glucose parameters were carried out.
Link to study report: http://bmjopen.bmj.com/content/4/10/e005138.abstract?sid=b1a813f8-138e-4eaa-9b01-6787541b9384
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 20,0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
About Bayer Zydus Pharma
Bayer Zydus Pharma, the joint venture company of Bayer HealthCare and Zydus Cadila, is backed by strong research and development and a novel therapeutic approach. Focused on patients' healthcare needs in India, Bayer Zydus Pharma offers innovative healthcare solutions in the area of women's healthcare, general medicine, specialty medicine and diagnostic imaging.
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