Harshvardhan Gupta's life revolved around his ailment. Following the diagnosis of diabetes at age 33, diet and exercise ruled his life. Despite a regular dose of 135 units of insulin, his diabetes was not in control. High blood pressure, high cholesterol and sleep apnoea added to his woes. “I was just waiting for one of my organs to fail. Life seemed terrible and I was always tired,” says the 58-year-old Mumbaikar.
Despite managing their diet and lifestyle, many like Gupta are unable to check the progress of the disease. Diabetes affects the kidney, eyes, nerves as well as blood vessels, increasing the risk for heart ailments. Making it worse is the Indian's propensity to diabetes. “Despite the fact that India is a thin country, Indians are the largest ethnic group vulnerable to type 2 diabetes and that, too, at a much lower BMI,” says Dr David E. Cummings, professor of medicine, division of metabolism, endocrinology and nutrition, University of Washington. It is the abdominal fat in Indians as well as the thrifty Indian phenotype, which makes Indians prone to insulin resistance, say experts.
Dr Shashank Shah, director at laparo-obeso centre at Ruby Hall Clinic, Pune, and president of the Obesity Surgery Society of India, has seen countless cases of diabetics suffering in spite of best medical therapy. “The mean BMI of Indians suffering from diabetes is 27, which is much lower than the global average. Also since the minimum standards for conducting a gastric bypass surgery is over BMI 32.5, most diabetics in India would never reach that weight and would never be eligible for surgery though they need it,” he says. It is a well-known fact that gastric bypass surgery, which is performed on morbidly obese patients to lose weight, also helps control diabetes and in many cases, cures it. Now, doctors are trying to find out the result of gastric bypass or metabolic surgery on diabetics who are not obese or overweight.
A study on the same lines is currently being conducted in India by Shah and Dr Jayashree Todkar, consultant general and laparoscopic surgeon at laparo-obeso centre, Ruby Hall Clinic and Poona Hospital. Called the COSMID study, it is a randomised controlled trial to compare the results of medical therapy versus surgery for over 88 diabetics. In the study, one randomly selected group will be given the best kind of medical treatment and consultation on diet and exercise. The other group will undergo a Roux-en-Y gastric bypass surgery (RYGB).
RYGB surgery is one of the more popular bariatric surgeries. It reduces the size of the stomach and bypasses the food to a lower part of small intestine. Post surgery, patients can only eat a small amount of food at a particular time and the absorption of nutrients from the food is also reduced, helping the patient lose up to half of their excess weight.
The procedure has a surprising effect on diabetics, too. Since the food directly goes to the lower part of the small intestine, a hormone called ghrelin is not secreted, which helps insulin action. Also due to the surgery, levels of incretin increase. Incretin hormone stimulates the pancreas to secrete more insulin and also improves insulin sensitivity keeping blood sugar levels under control.
Till now, the results have been encouraging for other randomly conducted studies. The most recent trial named Stampede study was published in the New England Journal of Medicine in August last year. At least 42 per cent of patients who underwent RYGB surgery reached the primary end point of having blood sugar levels under control, compared to 12 per cent of patients in the medical therapy group.
Since Indians have ethnic differences from Europeans and with our genetic profile making us more prone to diabetes, bariatric surgeons have been keen on studying the effect of the procedure on Indians. In a pilot study conducted by Shah and Todkar four years ago, 15 patients with severe diabetes, who were not morbidly obese, were selected for RYGB surgery. The results of the study were startling. In just a month, the average blood sugar level for all patients was about 100 and in nine months, the levels dropped to 89, which is considered normal. Also, almost 80 per cent of the patients were off diabetes medicines by the first month and all of them were off the medicines by the third month.
Gupta was one of the 15 patients selected by Shah. “I was off insulin, three days after the surgery,” says Gupta. He lost the stubborn belly fat and got his vitality and health back. “At 58, I feel as active as I was when I was 30,” he says. For two years after the surgery, he did not need any medication, and was diagnosed with mild diabetes six months ago. He says the surgery gave him a new lease of life.
Kantibhai Patel agrees. The 63-year-old resident of Silvassa was overweight with uncontrolled diabetes. What bothered Patel was the constant numbing sensation in his leg due to neuropathy and erectile dysfunction, both common side effects of diabetes. Since his surgery in May last year, he has lost weight, his blood sugar levels are under control and his neuropathy and erectile dysfunction are getting better.
Encouraged by the possibilities, Shah submitted the results of the study and received a grant by the US Metabolic Council and Worldwide Metabolic Council for the COSMID study. Cummings who is the expert advisor for the study and supervises the quality, feels the study has significant implications for Indians. “WHO says, by 2030, India would have 75 million diabetics, about half of the world's diabetic population. In such a scenario, any tool that will bear the tide would be a good one and a surgical intervention seems like a good option at the moment."
But it would be too early for gastric bypass to be considered a form of treatment for diabetes. Gastric bypass remains an option more for obesity than for treating diabetes, feels Dr V. Mohan, chairman and chief diabetologist at Dr Mohan's Diabetes Specialities Centre in Chennai. “I would recommend gastric bypass survey in those with morbid obesity and severe diabetes or obese people requiring large doses of insulin,” he says. Dr Dheeraj Kapoor, endocrinologist at Kokilaben Dhirubhai Ambani Hospital, Mumbai, agrees: “Diabetic Association's guidelines says that gastric bypass surgery can be an alternative for those who are obese and who in spite of lifestyle modifications have not been able to control their diabetes.”
However, there are no doubts about its efficacy. “The benefit is that in obese patients, who have severe insulin resistance, gastric bypass surgery is able to bring down the blood glucose levels considerably both due to hormonal changes and weight loss. Many patients are able to go off insulin and some [reduce the dosage to] even half tablets,” says Mohan. However, experts feel that there is still no long-term data available to show the effects of the surgery on diabetes. Shah himself says that in about 10 per cent of patients, diabetes may come back a few years after the surgery though it might be mild.
Risks associated with surgery are there, too. There is about 0.5-1.5 per cent risk for mortality and 0.2 per cent risk of infections post surgery. In some cases, the surgery can cause malabsorption of nutrients and patients are required to take nutritional supplements to prevent deficiency. Also, costing about 03-4 lakh, the surgery remains out of reach for many diabetics. Todkar, however, thinks it is justified. “A diabetic patient spends about 010,000 on drugs per month," she says. "The cost of the surgery is then recovered in just three to four years, if the diabetes goes away.”