Background: Effective and safe treatments for obesity and type 2 diabetes are urgently needed. The endoscopically placed duodenal-jejunal bypass sleeve (DJBS) (Endobarrier®) proposes to impair digestion and absorption of macronutrients, thus inducing weight loss. Absorption of micronutrients may therefore also be impaired.
Aim: To assess the safety, efficacy, and mechanisms of the DJBS in 4 pilot patients with obesity and type 2 diabetes who had failed all previous conservative interventions.
Methods: The DJBS was placed endoscopically and left in-situ for 48 weeks. Subjects received medical and dietetic support throughout. Metabolic, functional, psychological and dietary intake investigations were performed at baseline, and monthly or bi-monthly thereafter.
Results: All patients completed the 48 week period with devices in place. No device-related events were observed. The median weight loss was 27.85 kg (21.5 – 32.4), or 23.17% (19.76 – 26.51) of body weight. During the study period, mean daily energy intake was reduced as compared to baseline (baseline mean 6737 kJ (range 5156-7750) as compared to week 48: 3845 kJ (range 3442 – 5871)). Liver function tests substantially improved (median alanine transaminase baseline 37 U/L (15.5 – 73.5) as compared to week 48: 17 U/L (12.5 – 22.5); median aspartate transaminase baseline 25.5 U/L (21.5 – 51.5) as compared to week 48: 18 U/L (15 – 22)). In parallel, median glycated haemoglobin decreased from 6.8% (range 5.9-7.9) to 5.8% (range 5.7-6.0)) at week 48. No significant decrease in circulating micronutrient concentrations was observed. Dietary quality did not change.
Conclusion: Weight loss during treatment with a DJBS in the setting of a multi professional team approach is clinically meaningful and appears to be largely explained by decreased energy intake. The small pilot study did not provide evidence for malabsorption of micronutrients.