PMID- 29225893 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220314 IS - 2052-4897 (Print) IS - 2052-4897 (Electronic) IS - 2052-4897 (Linking) VI - 5 IP - 1 DP - 2017 TI - A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway. PG - e000431 LID - 10.1136/bmjdrc-2017-000431 [doi] LID - e000431 AB - 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/m(2), 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. FAU - Fried, Martin AU - Fried M AD - OB Klinika a.s, Prague, Czech Republic. AD - 1st Faculty of Medicine, Charles University, Prague, Czech Republic. FAU - Dolezalova, Karin AU - Dolezalova K AD - OB Klinika a.s, Prague, Czech Republic. AD - 1st Faculty of Medicine, Charles University, Prague, Czech Republic. FAU - Chambers, Adam P AU - Chambers AP AD - GLP-1 & Obesity Pharmacology, Novo Nordisk A/S, Malov, Denmark. FAU - Fegelman, Elliott J AU - Fegelman EJ AD - Ethicon, Inc, Cincinnati, OH, USA. FAU - Scamuffa, Robin AU - Scamuffa R AD - Ethicon, Inc, Cincinnati, OH, USA. FAU - Schwiers, Michael L AU - Schwiers ML AD - Ethicon, Inc, Cincinnati, OH, USA. FAU - Waggoner, Jason R AU - Waggoner JR AD - Ethicon, Inc, Cincinnati, OH, USA. FAU - Haluzik, Martin AU - Haluzik M AD - Institute for Clinical and Experimental Medicine, Centre for Experimental Medicine, Diabetes Centre, Prague, Czech Republic. FAU - Seeley, Randy J AU - Seeley RJ AD - Department of Surgery, Internal Medicine and Nutritional Science, University of Michigan, Ann Arbor, MI, USA. LA - eng SI - ClinicalTrials.gov/NCT02283632 GR - P30 DK020572/DK/NIDDK NIH HHS/United States PT - Journal Article DEP - 20170901 PL - England TA - BMJ Open Diabetes Res Care JT - BMJ open diabetes research & care JID - 101641391 PMC - PMC5706485 OTO - NOTNLM OT - Metabolic OT - Surgery OT - Type 2 Diabetes COIS- 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. EDAT- 2017/12/12 06:00 MHDA- 2017/12/12 06:01 PMCR- 2017/09/01 CRDT- 2017/12/12 06:00 PHST- 2017/04/17 00:00 [received] PHST- 2017/07/20 00:00 [revised] PHST- 2017/07/26 00:00 [accepted] PHST- 2017/12/12 06:00 [entrez] PHST- 2017/12/12 06:00 [pubmed] PHST- 2017/12/12 06:01 [medline] PHST- 2017/09/01 00:00 [pmc-release] AID - bmjdrc-2017-000431 [pii] AID - 10.1136/bmjdrc-2017-000431 [doi] PST - epublish SO - BMJ Open Diabetes Res Care. 2017 Sep 1;5(1):e000431. doi: 10.1136/bmjdrc-2017-000431. eCollection 2017.