Duodenal mucosal resurfacing combined with glucagon-like peptide-1 receptor agonism to discontinue insulin in type 2 diabetes: a feasibility study.

BACKGROUND AND AIMS: Duodenal mucosal resurfacing (DMR) is an endoscopic intervention in which the duodenal mucosa is ablated by hydrothermal energy. DMR improves glycemic control in patients with type 2 diabetes (T2D), most likely by altered duodenal signaling leading to insulin sensitization. We studied whether we could discontinue insulin use in T2D patients by combining DMR with glucagon-like peptide-1 receptor agonist (GLP-1RA) and lifestyle counseling. METHODS: In this single-arm, single-center feasibility study in 16 insulin-treated patients with T2D (hemoglobin A1c [HbA1c] ≤8.0%, basal insulin <1 U/kg/day, C-peptide ≥.5 nmol/L), patients underwent a single DMR followed by a 2-week postprocedural diet, after which GLP-1RA (liraglutide) was introduced. Lifestyle counseling was provided per American Diabetes Association guidelines. The primary endpoint was percentage of patients without insulin with an HbA1c ≤7.5% (responders) at 6 months. Secondary endpoints were changes in multiple glycemic and metabolic parameters and percentage of responders at 12 and 18 months, respectively. RESULTS: All 16 patients underwent successful DMR without procedure-related serious adverse events. At 6 months, 69% of patients were off insulin therapy with an HbA1c ≤7.5%. At 12 and 18 months 56% and 53% remained off insulin, respectively. All patients significantly improved in the glycemic and metabolic parameters of homeostatic model assessment for insulin resistance, body mass index, weight, and liver fat fraction. CONCLUSIONS: In this feasibility study, the combination of a single DMR and GLP-1RA, supported by lifestyle counseling, eliminated the need for insulin therapy in most patients with T2D through 18 months postprocedure, with adequate beta-cell capacity, while improving glucose regulation and metabolic health in all patients. A randomized-sham controlled trial is currently initiated based on these results. (Clinical trial registration number: EudraCT 2017-00349-30.).

Reliability and usefulness of upper gastro intestinal contrast studies to assess pouch size in patients with weight loss failure after Roux-en-Y gastric bypass.

Background: Weight loss failure or weight regain occurs in up to 25% of patients with a Roux-en-Y gastric bypass (RYGB). Post-operative anatomical changes, like pouch or stoma dilatation, might contribute. Aim of this study is to assess reliability and usefulness of upper gastro intestinal (UGI) contrast studies to detect pouch dilatation.Methods: Retrospective case-control study of patients with weight loss failure between 2010 and 2015 (failure group, n = 101) and a control group (n = 101) with adequate weight loss. Pouch dilatation was systematically reassessed. Clinical parameters were extracted from the electronic patient records.Results: Systematic reassessment showed 23/101 (23%) pouch dilatation in the failure group, compared to 11/101 (11%) in the control group (p = .024). Revision surgery was performed in 43/101 patients in the failure group. After this surgery, only 8% of patients with pouch dilatation achieved adequate weight loss, whereas 39% of patients without pouch dilatation achieved adequate weight loss (p = .07). There was no difference in return to adequate weight loss between patients treated surgically and conservatively (30% vs 28%).Conclusion: Systematic reassessment of UGI contrast studies showed 23% pouch dilatation in patients with weight loss failure after RYGB. However, low interobserver agreement and discrepancy in success rate of revision surgery greatly questions the reliability and usefulness of this diagnostic modality.

Substitution of hospital care with Primary Care Plus: differences in referral patterns according to specialty, specialist and diagnosis group.

BACKGROUND: Primary Care Plus (PC+) is an intervention where patients consult specialists in a primary care setting outside the hospital. Two facilities have been founded in the city of Maastricht, the Netherlands. Main aim is to achieve substitution of hospital care with primary care and hence reduce costs. The objective of this study is to evaluate referral patterns per specialty, specialist and diagnosis group, as input for deliberations to optimise substitution. METHODS: Prospectively collected referral data after PC+ consultations between November 2014 and March 2016 was analysed for eight participating specialties. Primary outcomes were differences in referral patterns per specialty, specialist and diagnosis group. Absolute counts and percentages were recorded for categorical variables, means and standard deviations for continuous variables. Statistical analyses were performed using IBM SPSS Statistics 23 (SPSS Inc., Chicago, IL). RESULTS: In total 4536 patients were seen in PC+; 3132 (69.0%) were referred back to the general practitioner (GP), whereas 1275 (28.1%) were referred to secondary care. Referral information of 130 (2.9%) patients was unknown. Large differences in referral numbers to secondary care after PC+ consultation were found between specialties (from 8.6% (gynaecology) to 43.8% (orthopaedic surgery)), specialists (14.5 to 65.2%) and diagnosis groups (11.1 to 93.4%). CONCLUSIONS: Wide variation in referral numbers to secondary care between specialties, specialists and diagnosis groups exists after PC+ consultations. This data indicates that deliberation and further research is needed in order to optimize substitution initiatives like PC+.