Thompson, Christopher C.

Objective: An endoscopically placed duodenal-jejunal bypass liner (DJBL) may provide a safe adjunctive therapy for those with poorly controlled type 2 diabetes mellitus (T2DM) and obesity. Background: Although some endoscopic therapies have been shown to improve glycemic indices secondary to weight loss, small bowel interventions may have direct metabolic effects. A meta-analysis of observational studies demonstrated reduction in HbA1c by 1.3% at 1 year after DJBL in patients with T2DM and obesity. Methods: This was a multicenter, double-blind, randomized, sham-controlled trial comparing DJBL to sham procedure with medical management and lifestyle modification. Primary endpoints included mean difference in changes in HbA1c at 12 months between arms, and device-related serious adverse events (SAEs). Secondary endpoints included percent total weight loss (%TWL) and subjects achieving HbA1c≤7% and TWL≥5% at 12 months. Results: Three hundred twenty subjects were randomized to DJBL (n=212) and sham (n=108). Baseline HbA1c and BMI were 8.79±0.92% and 38.45±5.75 kg/m 2 . On modified intent-to-treat analysis, change in HbA1c at 12 months was −1.10±1.45% and −0.28±1.54% for DJBL and sham groups, respectively ( P =0.0004). Rate of device-related SAEs was 9.4% including intolerance (3.7%), hemorrhage (2.8%), and hepatic abscess (2.3% stopping study early). At 12 months, DJBL group experienced greater weight loss compared with sham (7.7±9.6% TWL and 2.1±5.4% TWL, respectively; P <0.0001), with significantly more patients achieving HbA1c ≤ 7% (28.3% vs. 9.4%; P <0.0003) and TWL ≥ 5% (60.4% vs. 21.3%; P <0.0001). Conclusions: DJBL met primary glycemic control efficacy and primary safety endpoints, while providing clinically significant weight loss, and comorbidity improvement.

AbstractThis joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0–29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Background Despite initial successful weight loss, some patients may experience weight regain following Roux-en-Y gastric bypass (RYGB). Objective To assess the impact of weight regain on bariatric patients’ quality of life (QoL). Methods This was a prospective cross-sectional study. Fifty-six consecutive RYGB patients were recruited and divided into weight-regain and weight-stable cohorts. QoL was assessed using the Bariatric Quality of Life (BQL) questionnaire. The BQL Index scores of the weight-regain and weight-stable groups were compared using Student’s t -test. Additionally, the BQL Index score of the weight-regain group was compared with that of historical prebariatric patients. Predictors of BQL were assessed using univariate and multivariate linear regression analyses. Results Of 56 RYGB patients, 41 (73%) had weight regain. On average, patients had body mass index (BMI) of 37 ±7.5 kg/m 2 and gained 34 ±26% of maximal weight initially lost. Weight-regain patients had lower BQL Index scores than weight-stable patients (44.8±6 vs 53±7, p<0.001). Patients with weight regain had similar BQL Index scores as the prebariatric patients despite lower BMI (BMI of 39.7±6.8 vs 47.2±7.6, p<0.05; BQL Index of 44.8±6 vs 41.6±10.4, p=0.144, respectively). Years from RYGB, BMI and amount of weight regain were associated with BQL Index on a univariate analysis (β=−0.55,−0.52, −0.7; p<0.0001). Only weight regain was a significant predictor of BQL on a multivariate analysis (β =−0.56; p=0.001). Conclusion Weight regain had a negative impact on bariatric patients’ QoL. Patients who regained at least 15% of maximal weight lost appeared to have as low QoL as those who had not undergone bariatric surgery despite a lower BMI.