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By Monica Smith

Baltimore—In obese patients who receive a duodenal-jejunal bypass liner (DJBL), glycemic control may be a more significant predictor of successful weight loss than the presence or absence of type 2 diabetes, according to recently presented research.

A DJBL is a highly flexible, nutrient-impermeable, 60-cm sleeve placed endoscopically that covers the entire duodenum and the first portion of the jejunum.

“After one year of treatment, patients with a DJBL lose an average of 47% of their excess weight. However, as with bariatric surgery, weight loss is variable with this device,” said Rodrigo Munoz, MD, PhD, Departamento de Cirugia Digestiva, Escuela de Medicina, Pontificia, Universidad Catolica de Chile, in Santiago, Chile.

“The aim of this study was to identify clinical predictors of weight loss in this group of patients treated with this device for one year.”

The study was presented at the 2013 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

Seeking a correlation between baseline variables and weight loss, Dr. Munoz and his colleagues collected data every month for one year on 61 patients treated with a DJBL. The collected variables included demographic information, baseline comorbidities, and anthropometric and biochemical characteristics.

The majority of the patients were women, with an average age of 35 years and average body mass index of 43 kg/m2. Twenty-one of the patients (34%) had type 2 diabetes. At one year, the average percentage of excess body weight loss was 47%, with some patients at either extreme, having lost little of their excess weight or almost all of it. Coincidentally, nine patients (14.7%) lost more than the average, and nine lost less than the average.

“Our univariate analysis indicated three variables inversely associated with weight loss at one year: insulin resistance determined by HOMA [homeostatic model assessment], fasting glycemia and Hb [hemoglobin]A1c,” Dr. Munoz said. “But after we controlled for all these three variables, only HbA1c was inversely and independently associated with the weight loss effect of this device.” In contrast with previous studies, the presence of type 2 diabetes did not affect the weight loss effect of the DJBL.

Dr. Munoz concluded that placement of a DJBL can result in significant weight loss in both patients with and without type 2 diabetes, and that patients with higher baseline levels of HbA1c could benefit from early intervention to optimize the weight loss effect of this device.

Dr. Munoz also said that the baseline levels of HbA1c in the group of patients with type 2 diabetes averaged 6.7%, which indicated good glycemic control and HbA1c levels in the patients without type 2 diabetes averaged 6%. A larger trial could yield different results.

“The differences in baseline HbA1c between diabetic and nondiabetic patients are not great, and I suspect that this relationship may disappear in a prospective trial with more patients,” said Jon Gould, MD, chief, Division of Surgery, Alonzo P. Walker Chair in Surgery and associate professor of surgery, Medical College of Wisconsin in Milwaukee.

“The demographics of the study group suggest these patients would otherwise have been candidates for bariatric surgery. The mean weight loss seems pretty good for an entirely endoscopic procedure using an implantable device, so I think it is notable that the weight loss was so good,” Dr. Gould said. “I would be interested to know how many of the diabetics were no longer diabetic after a year.”

Dr. Munoz and his team are currently analyzing several gut-derived peptides and important metabolites involved in body weight and glucose regulation from blood samples obtained in a fasting condition and after a standard meal test of DJBL recipients. The samples will be taken monthly for a year.

“This new set of data will help us to have a better understanding of how this device impacts a patient’s physiology, and how these changes correlate with weight loss and metabolic outcomes,” Dr. Munoz said.