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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.
- Metabolic
- Type 2 Diabetes
- Surgery
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Footnotes
Contributors MF was involved in the clinical study design, execution, data collection and interpretation, and manuscript review and final approval. KD was involved in clinical study execution, data collection and interpretation, and manuscript review and final approval. APC was involved in the pre-clinical study design, execution, data collection and interpretation of the pre-clinical work, and manuscript preparation and final approval. EJF was involved in the clinical study design, data interpretation, and manuscript review and final approval. RS was involved in data interpretation, manuscript preparation and final approval. MLS was involved in the clinical study design, statistical analysis, data interpretation, manuscript review and final approval. JRW was involved in the clinical study design, data interpretation, manuscript preparation and final approval. MH was involved in the data interpretation, manuscript review and final approval. RJS was involved in the pre-clinical study design, data collection and interpretation of the pre-clinical work, clinical study design, data interpretation, manuscript review and final approval. All authors have reviewed and approved the completed manuscript.
Funding Funding for this study has been provided by Ethicon, Inc and by RVO VFN64165 from MHCR to MH.
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.
Patient consent Informed consent was previously obtained from all study patients.
Ethics approval Ethics Committee of the OB Clinic, Prague, Czech Republic.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement This manuscript includes all the data available.