pISSN 2636-0004
eISSN 2636-0012

Table. 1.

Clinical Outcomes of Duodenal Mucosal Resurfacing for Type 2 Diabetes Mellitus

Author (year) Study design Intervention Total (n) Inclusion criteria Outcome Notes
Rajagopalan et al17 (2016) Single-arm
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)
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
DMR combined with GLP-1RA
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
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

Int J Gastrointest Interv 2023;12:64~68 https://doi.org/10.18528/ijgii220018
© Int J Gastrointest Interv