pISSN 2636-0004eISSN 2636-0012
pISSN 2636-0004Clinical Outcomes of Duodenal Mucosal Resurfacing for Type 2 Diabetes Mellitus
| Author (year) | Study design | Intervention | Total ( |
Inclusion criteria | Outcome | Notes |
|---|---|---|---|---|---|---|
| Rajagopalan et al17 (2016) | Single-arm Open-label |
DMR | 39 | HbA1c 7.5%–12.0% with BMI ≥ 31 kg/m2 | HbA1c was reduced by 1.2% at 6 months | Three patients experienced duodenal stenosis |
| Hadefi et al18 (2018) | Case report | DMR | 1 | 44-year-old, overweight (BMI = 28 kg/m2) with T2D treated with OHA | HbA1c decreased by 1.2% (8.2% to 7.0%) at 3 months | Presented with a video demonstration |
| van Baar et al19 (2020) | Multi-center (seven sites, internationally) Single-arm Open-label |
DMR | 46 | HbA1c 7.5%–10.0% with BMI 24–40 kg/m2 | HbA1c was reduced by 0.9% at 24 weeks, with preservation of the effect up to 12 months HOMA-IR was reduced by 2.9 at 24 weeks, by 3.3 at 12 months |
DMR was completed successfully in 80% of the enrolled patients 81% of adverse events related to DMR was classified as ‘mild’ |
| van Baar et al20 (2021) | Single-arm Open-label |
DMR combined with GLP-1RA (liraglutide) |
16 | HbA1c < 8.0% with BMI 24–40 kg/m2 with fasting C-peptide > 0.5 nmol/L using long-acting insulin | 69% patients met adequate glycemic control at 6-month follow-up without insulin, 56% patients were still responders at the 12-month follow-up | No device-related AEs or treatment-related SAEs were reported |
| Mingrone et al21 (2022) | Double-blind RCT | DMR Control |
DMR, 56; sham, 52 | HbA1c 7.5%–10.0%, BMI 24–40 kg/m2, fasting insulin > 48.6 pmol/L with ≥ 1 OHA | HbA1c change was –6.6 mmol/mol in DMR group versus –3.3 mmol/mol post-sham 12-week post-DMR liver-fat change was –5.4% in DMR group versus –2.2% post-sham |
South American cohort failed to prove relative efficacy of DMR in liver fat reduction |
DMR, duodenal mucosal resurfacing; HbA1c, hemoglobin A1c; BMI, body mass index; T2D, type 2 diabetes mellitus; OHA, oral hypoglycemic agent; HOMA-IR, homeostatic model assessment for insulin resistance; RCT, randomized controlled trial