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Banding and T2DM

Banding improves glycaemic control in overweight T2DM patients

12 (52%) banding patients and two (8%) patients in the multidisciplinary care group achieved diabetes remission
Two-year weight loss was significantly greater in patients in the gastric band group

Laparoscopic adjustable gastric band surgery in overweight people with type 2 diabetes improves glycaemic control, according to the results of an Australian randomised clinical trial. The study, published in the journal The Lancet Diabetes and Endocrinology, compared multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone.

The authors concluded that banding combined with multidisciplinary diabetes care for overweight T2DM patients is more effective for control of blood glucose concentrations than is multidisciplinary care alone.

“This is the first randomised controlled trial demonstrating that treatment of type 2 diabetes in overweight people by substantial weight loss is safe and beneficial,” said study lead, Emeritus Professor Paul O’Brien from the Centre for Obesity Research and Education (CORE), Monash University, Melbourne, Australia. “As there are no alternative options that can achieve such a result, this study indicates a potentially attractive path for the overweight person with diabetes and for those providing their care.”

Study

The researchers performed an open-label, parallel-group, randomised controlled trial at one centre in Melbourne, Australia, which recruited 51 patients who were randomised to receive either multidisciplinary care (n=26) or multidisciplinary care plus laparoscopic adjustable gastric band surgery (n=25) between November 2009 and June  2011.

Patients were aged 18–65 years with type 2 diabetes and a BMI 25-30. The primary outcome was diabetes remission two years after randomisation (defined as glucose concentrations of less than 7·0 mmol/L when fasting and less than 11·1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs). Baseline characteristics were similar between treatment groups.

“We provided a comprehensive programme of multidisciplinary care to all of the participants, but randomly allocated half of them to receive an additional treatment of adjustable gastric banding,” explained O’Brien.

Outcomes

At two years, 25 patients who received multidisciplinary care alone and 23 patients who received multidisciplinary care plus banding, completed follow-up.

The researchers reported that 12 (52%) banding patients and two (8%) patients in the multidisciplinary care group achieved remission (p=0·0012). They found that in both groups, remission of diabetes was associated with weight loss of >8% bodyweight. Two-year weight loss was significantly greater in patients in the gastric band group (–11·5 kg change, p<0·0001 vs. –1.6kg change, p=0·21).

In addition, HbA1c declined during the two-year period reaching an average reduction of 0·8 percentage points (p<0·0001) for patients in the gastric band group, despite four (17%) of them stopping insulin and another five (22%) stopping oral glucose-lowering drugs.

In the multidisciplinary care group, despite greater glucose-lowering drugs use

HbA1c decreased to a lesser extent and this reduction was not sustained at two-years. More patients in the gastric band group achieved HBA1c target than in the multidisciplinary care group.

Paul O'Brien

“The surgery was conducted as an outpatient procedure with no significant adverse effects,” said O’Brien. “What we were pleased to see was that after two years into the trial, more than half of the banded group were in remission of their diabetes while only eight per cent of the non-banded group were in remission.”

Banding patients also had meaningful changes in diastolic blood pressure, and concentrations of HDL cholesterol and triglycerides, whereas patients in the multidisciplinary care group only had reduced concentrations of total cholesterol, LDL cholesterol and triglycerides at two-years.

“In view of unsatisfactory weight and diabetes outcomes for lifestyle intervention, these findings challenge present guidelines for the use of bariatric surgery in patients with type 2 diabetes, which recommend a BMI threshold of 35kg/m²,” the authors conclude. “The favourable safety profile and widespread acceptance of laparoscopic adjustable gastric band surgery argue for a more prominent place for this surgery in management of type 2 diabetes in overweight people,”

Co-authors of the study were John M Wentworth, Julie Playfair, Cheryl Laurie, Matthew E Ritchie, Wendy A Brown, Paul Burton and Jonathan E Shaw.

The study was funded by Monash University Centre for Obesity Research and Education and Allergan, although the company had no role in study design, data collection, data analysis, data interpretation or writing of the report.

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