Study doesn't support DJBL for weight loss in patients with metabolic syndrome
Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients with Metabolic Syndrome was assessed by researchers in ENDOMETAB trial and found the results don't support its routine use for weight loss and blood sugar control in metabolic syndrome.
Conventional medical care for metabolic syndrome involves combination of dietary advice, physical activity and psychological treatment which offers only limited results, both in weight reduction and comorbidities. Bariatric surgery allows however a significant and sustained weight loss in the majority of cases, and a decrease in the frequency and severity of co-morbidities, including type 2 diabetes, and decreased mortality including cardiovascular. Different techniques that may replace surgery are currently being developed.
In ENDOMETAB trial researchers assessed the safety and efficacy of DJBL (duodeno-jejunal bypass liner), an endoscopic device for treating obesity and related disorders. The trial details were published on Annals of Surgery in 25, November 2020.
It was a multicenter, randomized controlled trial involving 82 patients (67.5% female, 48.8% with diabetes) with metabolic syndrome (MS). Researchers designed the study with an objective to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care. They determined primary endpoints as the rate of resolution of Metabolic Syndrome at 1 year, measured by the frequency of patients without MS at 12 months. The secondary endpoints assessed were body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of DJBL.
KEY FINDINGS OF THE TRIAL WERE:
Among 82 patients 6 in DJBL patients (12%)and 3 in conventional care (10%) reached the primary endpoints.
Researchers found patients in the DJBL group experienced greater BMI loss when compared with the control group.
They also found significant changes in HbA1c levels of patients in the DJBL group than those in the control group.
However, there were no statistically significant differences noted at 12 months after the removal of the DJBL.
In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%.
The ENDOMETAB trial findings showed a transient clinical benefit of DJBL for a year when the device was in place with 39% device related serious adverse events.
The authors concluded, "These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS".
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