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Right way, wrong samples

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  • The failure of the intensive treatment arm of ACCORD (Action to Control Cardiovascular Risk in Diabetes), a study funded by the US National Institutes of Health, has raised several questions about the age-old belief that maintaining a low blood sugar is the best a diabetic patient can do.

    The study, which was to be completed in 2009, had to be stopped midway after a preliminary analysis revealed that patients given intensive treatment to lower their blood sugar were more likely to die than those given less intense treatment.

    Accord had enrolled 10,251 participants, of whom, 257 in the intensive treatment group have died, compared with 203 in the standard treatment group. The difference of 54 deaths, or 3 per 1,000 participants each year, over almost four years paints a grim picture. While the international medical fraternity is still awaiting more reports, the Indian doctors are looking into the possible reasons that led to the failure of the study.

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    Idea behind the study

    The ACCORD study was designed to test the effects of intensive control of blood sugar along with aggressive control of blood pressure and lipids.

    What went wrong?

    According to experts here who were avidly following the research, the very target sample - with people over 60 years in age who had some history of cardiac disorders, led to its failure. The doctors insist that the HBA1C level (level of glucose in blood, measured by the percentage of haemoglobin that has glucose stuck to it), ideally maintained at 7 per cent, should not be allowed to drop below 6.5 per cent. But in case of some patients here, it was brought to 6 per cent. The very diagnosis of diabetes implies that 50 per cent of insulin in the body is ineffective, explains Dr Ashok Jhingan, chairman, Delhi Diabetes Research Centre. Also those above 60 are already a prey to one or the other cognitive disorder. “Adoption of intensive measures like usage of insulin pumps and sugar-control pills, in such cases, led to further complications like hypoglycemia. A younger group of sample patients would have led to an interesting insight,” Dr Jhingan says.

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