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In obesity with type 2 diabetes, duodenal-jejunal bypass liners improved weight loss and HbA1c during treatment 多多多多多多夞

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Koehestanie P, de Jonge C, Berends FJ, et al. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. 2014;260:984-92.

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Question

Conclusions

In patients with obesity and type 2 diabetes, does adding an endoscopic duodenal–jejunal bypass liner (DJBL) to a dietary intervention improve weight loss and hemoglobin (Hb) A1c levels?

In obese patients with type 2 diabetes, adding a duodenal– jejunal bypass liner to a dietary intervention improved weight loss and HbA1c levels at 6 months. These effects were not maintained 6 months after removal of the liner.

Methods Design: Randomized controlled trial (RCT). Allocation: Unclear allocation concealment.* Blinding: Unblinded.* Follow-up period: 6 and 12 months. Setting: 3 centers in the Netherlands. Patients: 77 patients 18 to 65 years of age (63% men for 73 patients) who had a body mass index 30 to 50 kg/m2, type 2 diabetes for < 10 years, and HbA1c level 7.5% to 10%. Exclusion criteria included weight loss > 4.5 kg in the past 12 weeks; active Helicobacter pylori or other infection; gastroesophageal reflux disorder; symptomatic gallstones or kidney stones; bleeding disorders; connective tissue disorders; substance abuse; iron deficiency; C-peptide level < 1.0 ng/mL; creatinine level > 180 mmol/L; or use of anticoagulants, corticosteroids, nonsteroidal antiinflammatory drugs, weight-loss drugs, or other drugs that affect gastrointestinal motility. Intervention: Single-use, endoscopic DJBL implanted for 6 months, prophylactic proton-pump inhibitor, and dietary intervention (maximum 1200 kcal for women and 1500 kcal for men) (n = 38); or dietary intervention alone (n = 39). Outcomes: Weight loss, HbA1c levels, blood pressure (BP), cholesterol levels, and adverse events (AEs). Patient follow-up: 86%.

Main results After 6 months of treatment, DJBL increased weight loss and reduced HbA1c levels compared with diet alone (Table). At 12 months, 6 months after DJBL removal, groups did not differ for weight loss, HbA1c level, or AEs (Table). DJBL had lower total cholesterol levels (3.7 vs 4.5 mmol/L, P = 0.02) and low-density lipoprotein cholesterol levels (2.0 vs 2.3 mmol/L, P < 0.05) than diet alone at 6, but not 12, months; groups did not differ for BP, highdensity lipoprotein cholesterol levels, or triglyceride levels at 6 or 12 months.

Duodenal-jejunal bypass liner (DJBL) plus dietary intervention (DI) vs DI alone in obese patients with type 2 diabetes† Outcomes‡

DJBL ⴙ DI

DI

At 6 mo

*See Glossary. Source of funding: GI Dynamics, Inc. For correspondence: Dr. J.W. Greve, Atrium Medical Center Parkstad, Heerlen, The Netherlands. E-mail [email protected]. 

Commentary Clinicians caring for severely obese patients (with or without diabetes) have several management options, which vary in invasiveness, AEs, cost, and effectiveness. Unfortunately, long-term control of obesity remains poor. To avoid some of the risks associated with surgery, as well as irreversible anatomical disruption, endoscopic procedures are being evaluated for approval by the US Food and Drug Administration. Endoscopic placement of a DJBL to impair macronutrient absorption and perhaps affect satiety is a newer technology that has not consistently shown strong efficacy for weight loss and has high rates of AEs (1). Koehestanie and colleagues report the results of a small RCT, which was supported by the manufacturer. Although the DJBL group had both statistically and clinically better weight loss and improved HbA1c levels than the diet-only group, the effect did not persist after the liner was removed at 6 months. The effect of keeping the liner in place longer or replacing it periodically is unknown but is a potential safety concern given the relatively high rates of AEs reported in the study. Side effects affecting appetite may also be a reason for the observed weight reductions. Nonetheless, weight loss is important and should be assessed over a longer follow-up period to determine the true value of DJBLs as an adjunctive tool in obesity management. Bariatric surgery can produce rapid improvements in diabetes and inflammatory markers within days after surgery (2). Favorable changes in gut-derived hormones and microbiota may account for these improvements and favor sustained weight control. On the other hand, placement of an artificial liner may foster formation of a pathogenic biofilm and disrupt gut-barrier function. A better understanding of the mechanisms for the long-term success of surgery will help to facilitate future design of endoscopically placed devices for improved weight regulation and diabetes control. Lawrence J. Cheskin, MD Johns Hopkins Bloomberg School of Public Health Gerard E. Mullin, MD Johns Hopkins University School of Medicine Baltimore, Maryland, USA

P value Weight loss, kg

5.3

< 0.05

Hemoglobin A1c level

10.6 7.0%

7.9%

< 0.05

Weight loss, kg

6.8

4.0

0.07

Hemoglobin A1c level

7.3%

8.0%

0.95

At 12 mo§

RRI (95% CI) Adverse events

76%

59%

29% (⫺5 to 82)

†Abbreviations defined in Glossary. RRI and CI calculated based on all randomized patients and event rates in article. ‡Article is unclear as to whether data reported are mean or median values.

References 1. Zechmeister-Koss I, Huic´ M, Fischer S; European Network for Health Technology Assessment (EUnetHTA). The duodenal-jejunal bypass liner for the treatment of type 2 diabetes mellitus and/or obesity: a systematic review. Obes Surg. 2014;24:310-23. 2. Samaras K, Viardot A, Botelho NK, Jenkins A, Lord RV. Immune cellmediated inflammation and the early improvements in glucose metabolism after gastric banding surgery. Diabetologia. 2013;56:2564-72.

§6 months after removal of DJBL.

17 February 2015 Annals of Internal Medicine ACP Journal Club Downloaded From: http://annals.org/ by a Penn State University Hershey User on 05/27/2015

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姝 2015 American College of Physicians

ACP Journal Club: in obesity with type 2 diabetes, duodenal-jejunal bypass liners improved weight loss and HbA1c during treatment.

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