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BMJ Open Diabetes Res Care. 2017 Sep 1;5(1):e000431. doi: 10.1136/bmjdrc-2017-000431. eCollection 2017.

A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway.

Author information

1
OB Klinika a.s, Prague, Czech Republic.
2
1st Faculty of Medicine, Charles University, Prague, Czech Republic.
3
GLP-1 & Obesity Pharmacology, Novo Nordisk A/S, Malov, Denmark.
4
Ethicon, Inc, Cincinnati, OH, USA.
5
Institute for Clinical and Experimental Medicine, Centre for Experimental Medicine, Diabetes Centre, Prague, Czech Republic.
6
Department of Surgery, Internal Medicine and Nutritional Science, University of Michigan, Ann Arbor, MI, USA.

Abstract

Objective:

To explore partial jejunal diversion (PJD) via a side-to-side jejuno-jejunostomy for improved glycemic control in type 2 diabetes mellitus (T2DM). PJD is an anatomy-sparing, technically simple surgery in comparison to the predominate metabolic procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). Positive results in a rodent model prompted a human proof-of-concept study.

Research design and methods:

Pre-clinically, 71 rats were studied in a model of metabolic dysfunction induced by a high-fat diet; 33 animals undergoing one of two lengths of PJD were compared with 18 undergoing sham, 10 RYGB and 10 jejuno-ileal bypass. Clinically, 15 adult subjects with treated but inadequately controlled T2DM (hemoglobin A1c (HbA1c) of 8.0%-11.0%), body mass index of 27.0-40.0 kg/m2, and C peptide ≥3 ng/mL were studied. Follow-up was at 2 weeks, and 3, 6, 9, and 12 months post-PJD.

Results:

Pre-clinically, positive impacts with PJD on glucose homeostasis, cholesterol, and body composition versus sham control were demonstrated. Clinically, PJD was performed successfully without serious complications. Twelve months post-surgery, the mean (SD) reduction from baseline in HbA1c was 2.3% (1.3) (p<0.01).

Conclusions:

PJD may provide an anatomy sparing, low-risk, intervention for poorly controlled T2DM without significant alteration of the patient's lifestyle. The proof-of-concept study is limited by a small sample size and advanced disease, with 80% of participants on insulin and a mean time since diagnosis of over 10 years. Further study is warranted.

Trial registration number:

NCT02283632; Pre-results.

KEYWORDS:

Metabolic; Surgery; Type 2 Diabetes

Conflict of interest statement

Competing interests: MF, KD, APC, and MH have nothing to declare. RJS currently receives funding from Ethicon, Inc. EJF, RS, MLS, and JRW are employed by Ethicon, Inc.

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