New data from the Institute for Clinical and Experimental Medications found that gastric plication and GI Dynamics’ EndoBarrier device therapy showed similar outcomes for patients with type 2 diabetes and obesity.
“On a basic science and mechanistic basis, both treatments (GP and EndoBarrier) substantially improved metabolic parameters and were associated with reduction in systemic inflammation as well as adipose tissue inflammation,” Dr. Anna Cinkajzlova, who presented the data, said in a press release. “In addition, it is interesting to note that GP and EndoBarrier produced similar results despite radically different approaches. It is important to caution that these results represent early data from a retrospective non-randomized comparison and must be studied further in the future.”
The findings indicated that both treatments were associated with a reduction in systemic inflammation and in subcutaneous adipose tissue inflammation. Neither procedure showed changes in circulating lipopolysaccharide protein levels or gut leakage. EndoBarrier saw greater reductions in blood sugar, insulin sensitivity and fasting glucose levels, but gastric plication saw a greater reduction in BMI and insulin dosage.
“This study is useful on many levels. It shows continued evidence of EndoBarrier efficacy across multiple health metrics, including standard blood sugar and weight metrics, as well as insulin sensitivity, fasting glucose, and key inflammatory mediators,” GI Dynamics president and CEO Scott Schorer said in the statement. “The study also presents early data indicating that EndoBarrier produces clinical efficacy that is on par with and in some cases superior to surgical gastric plication, which is a restrictive bariatric surgery. The fact that these results can be achieved in a minimally invasive treatment with EndoBarrier versus a full surgical procedure is very promising.”
The study was conducted with 40 patients, 10 who comprised the healthy control group and 30 with type 2 diabetes mellitus and obesity who were split into two groups. One group of 15 underwent gastric plication with measurements taken at treatment and one and six months after treatment. The other group was implanted with EndoBarrier with measurements taken at implant, one month in and at the ten-month explant.