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DNA
24 Aug 2012
88 patients undergo trial to find if surgery works on Indians as it does on Westerners

In a first of its kind comparative study in Asia, a surgeon’s scalpel is all set to challenge a physician’s medication in a bid to tackle diabetes.

A random controlled study of patients, who are obese with a basal metabolic index (BMI) between 25 and 40, and are suffering from uncontrolled diabetes, is underway in Maharashtra and Gujarat. Conducted by Indian and American doctors, 44 of the 88 enrolled patients are slated to be put on complete medication to cure diabetes, whereas the other half are to undergo a gastric bypass procedure to monitor the efficacy of medicine versus surgery.

Nineteen of the enrolled participants are from Mumbai and the others hail from Aurangabad, Silvassa and Pune. Even as three such studies have been carried out in the US, UK and Australia, doctors say that a separate analysis of the Indian population is necessary. This, experts say, is because close to 6% of the 1.2 billion Indians who suffer from Type 2 diabetes are obese and that Indians may have a special variant of diabetes which makes them up to four times more vulnerable to acquiring it than their western counterparts with the same levels of BMI.

Dr Shashank Shah, a consultant bariatric surgeon, said that this study was to independently analyse comparative results of Indian patients. "We are halfway through the study, with 23 patients having undergone the surgery. A recent study in New England Journal of Medicine (NEJM) showed that surgery is three times more effective than medicines in Type 2 diabetes," Shah said.

Convincing patients to enrol for the random trials was not easy. "Hardly one of the hundred patients approached agreed to be a part of it," said Dr David Cummings, principal investigator of the study from University of Washington. "Patients want to opt for surgery or medication but the study does not give them that option. We are now in the process of blindly selecting groups for the latter half of the trials to get the most objective results."

The sample size of patients is between 30 to 65 years with a BMI between 25 and 40. Currently, bariatric surgery is being carried out on people with a BMI above 35, but majority of Type 2 diabetic Indian patients have a BMI of 25 onwards. The study, slated to be published after two years, will establish new guidelines for appropriate surgical or medical intervention to benefit a majority of diabetics in the country, Dr Cummings said.

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