Vilarrasa Nuria, de Gordejuela Amador García Ruiz, Casajoana Anna, Duran Xevi, Toro Silvia, Espinet Eduard, Galvao Manoel, Vendrell Joan, López-Urdiales Rafael, Pérez Manuel, Pujol Jordi
Department of Endocrinology and Nutrition, Hospital Universitario de Bellvitge-IDIBELL, c/ Feixa Llarga s/n 08907, L'Hospitalet de Llobregat, Barcelona, Spain.
CIBERDEM-CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Madrid, Spain.
Obes Surg. 2017 Mar;27(3):569-577. doi: 10.1007/s11695-016-2311-0.
The purpose of this study was to evaluate the efficacy and safety of Endobarrier® in grade 1 obese T2DM patients with poor metabolic control and the role of gastro-intestinal hormone changes on the metabolic outcomes.
Twenty-one patients aged 54.1 ± 9.5 years, diabetes duration 14.8 ± 8.5 years, BMI 33.4 ± 1.9 kg/m, and HbA1c 9.1 ± 1.3 %, under insulin therapy, were implanted with Endobarrier®. Fasting concentrations of PYY, ghrelin and glucagon, and AUC for GLP-1 after a standard meal test were determined prior to and at months 1 and 12 after implantation.
Patients lost 14.9 ± 5.7 % of their total body weight. HbA1c decreased 1.3 % in the first month, but at the end of the study, the reduction was 0.6 %. HbA1c ≤ 7 % was achieved in 26.3 % of patients. No differences in GLP-1 AUC values were found before and after implant. Fasting plasma ghrelin and PYY concentrations increased from month 1 to 12. Conversely, fasting plasma glucagon concentrations decreased at month 1 and increased thereafter. Weight (β 0.152) and HbA1c decrease at month 1 (β 0.176) were the only variables predictive of HbA1c values at 12 months (adjusted R for the model 0.693, p = 0.001). Minor adverse events occurred in 14 % of patients and major events in 9.5 %.
Endobarrier® in T2DM patients with grade I obesity and poor metabolic control is associated with significant weight decrease and moderate reduction in HbA1c at month 12. Our data do not support a role for GLP-1 in the metabolic improvement in this subset of patients.
本研究旨在评估Endobarrier®对代谢控制不佳的1级肥胖2型糖尿病（T2DM）患者的疗效和安全性，以及胃肠激素变化对代谢结果的作用。
21例年龄为54.1±9.5岁、糖尿病病程14.8±8.5年、体重指数（BMI）为33.4±1.9kg/m²、糖化血红蛋白（HbA1c）为9.1±1.3%且正在接受胰岛素治疗的患者植入了Endobarrier®。在植入前以及植入后1个月和12个月时，测定餐后标准餐试验中肽YY（PYY）、胃饥饿素和胰高血糖素的空腹浓度以及胰高糖素样肽-1（GLP-1）的曲线下面积（AUC）。
患者体重减轻了14.9±5.7%。HbA1c在第1个月下降了1.3%，但在研究结束时，下降幅度为0.6%。26.3%的患者HbA1c≤7%。植入前后GLP-1的AUC值未发现差异。空腹血浆胃饥饿素和PYY浓度从第1个月到第12个月升高。相反，空腹血浆胰高血糖素浓度在第1个月下降，此后升高。体重下降（β0.152）和第1个月时HbA1c下降（β0.176）是12个月时HbA1c值的唯一预测变量（模型调整后的R²为0.693，p=0.001）。14%的患者发生轻微不良事件，9.5%的患者发生严重不良事件。
Endobarrier®用于1级肥胖且代谢控制不佳的T2DM患者，与显著体重减轻以及在12个月时HbA1c适度降低相关。我们的数据不支持GLP-1在该亚组患者代谢改善中发挥作用。
