One-year implantation of an endoscopic duodenal-jejunal bypass liner induces 20%weight loss and substantial improvement in type 2 diabetes and coronary heart disease (CHD) risk factors

Alex Escalona1 , Fernando Pimentel 1 , Allan Sharp 1 , Pablo Becerra 1 , Dannae Turiel 1 , Claudia Bambs 1 , Luis Ibáñez 1 Santiago, Chile; Manoel Galvao 2 ,Almino Ramos2 Sao Paulo, Brazil; Keith Gersin 3 , Charlotte, NC; Lee Kaplan 4 , Boston, MA [1 Pontifica Universidad Católica de Chile, Santiago, Chile, 2Gastro Obeso Center, Sao Paulo, Brazil 3Carolinas Medical Center, Charlotte, NC, 4Massachusetts General Hospital, Boston, MA, ]

Background:

The duodenal-jejunal bypass liner (DJBL, GI Dynamics, Inc., Lexington, MA,) is an endoscopic implant that mimics the intestinal bypass component of the Roux-en-Y gastric bypass (Figures 1 and 2). Previously reported studies have shown promising improvements in type 2 diabetes (T2D) and weight loss for up to 6 months. This report describes weight loss and metabolic changes in subjects with obesity who were implanted with the DJBL for one year.

Methods:

The DJBL was implanted endoscopically in 43 of 46 subjects (weight, 110.8±18.7 kg; BMI, 44.1±5.7 kg/m2; age, 35.0±10.0 years, 76.7% women). Three subjects could not be implanted due to unfavorable anatomy. Mean implant delivery time was 23±11 minutes. There were 16 early endoscopic removals due to device movement (9), liner obstruction (3), abdominal pain (2), acute cholecystitis (1) and patient request (1). Weight and cardiometabolic data were analyzed on the 27 subjects who completed the protocol to one year.

Results:

Observed weight loss at one year was 22.8±8.9 kg (p<0.0001) or 46.4±18.9% (Figure 3) of excess of weight loss. Metabolic improvements include decreases in waist circumference of 20.6±7.8 cm (p<0.0001), systolic blood pressure of 9.3±14.7 mmHg (p=0.003), diastolic blood pressure of 13.4±9.3 mmHg (p<0.0001), Total cholesterol of 35.5±30.7 mg/dL (p<0.0001), LDL cholesterol of 25.9±23.1 mg/dL (p<0.0001), triglycerides of 43.9±61.9 mg/dL (p=0.007). There was no change in HDL cholesterol (0.81±7.0 mg/dL) (p=0.5) (Figure 4). HbA1c decreased from 7.9±2 to 6.5±1.6% (p=0.05) in 6 subjects with T2D.

Conclusions:

The endoscopic DJBL has a durable effect on weight loss and metabolic function for one year, suggesting this new device may be a candidate for the primary therapy of T2D and obesity.

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