GI Dynamics’ EndoBarrier gastrointestinal liner has demonstrated improvement in glycaemic control and weight loss as part of a trial.
Seventeen obese patients with type 2 diabetes were treated with the EndoBarrier for 24 weeks.
The levels of HbA1c, glucose, insulin, GLP-1, GIP and PYY were assessed in each placement before and one week after the placement of the EndoBarrier, and before and one week after its removal.
The trial showed that EndoBarrier resulted in increased insulin sensitivity, increased levels of PYY and GLP-1 one-week post-placement, reduction in mean HbA1c levels of 1.4%, normalisation of glucagon response and mean excess weight loss of 29.8%.
Maastricht University Medical Centre, Netherlands, professor Charlotte de Jonge said that the data showed that treatment with the EndoBarrier affects key hormones involved in insulin sensitivity, glucose metabolism and satiety, similar to the impact of gastric bypass, and these changes allow for rapid and sustained improvement in patients with type 2 diabetes.
“In addition, we found that patients maintained diabetic improvements at the end of the follow-up period, one week post-removal. These are important findings in understanding how the EndoBarrier works to treat type 2 diabetes,” de Jonge said.
The EndoBarrier has received CE mark approval in Europe for implant periods of up to 12 months of treatment for type 2 diabetes and obesity, and recently received Therapeutic Goods Administration approval in Australia.
GI Dynamics has also received an investigational device exemption approval to begin a pilot clinical trial of the EndoBarrier in the US.