Evaluation of Endoscopic Band Ligation for Treatment of Type 2 Diabetes: A Single-Center Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Change in HbA1c level from baseline
研究概览
简要总结
This is a pilot clinical study evaluating the safety and feasibility of Endoscopic Band Ligation (ENDOBAND-DM) applied to the second through fourth parts of the duodenum - from just distal to the ampulla of Vater to the ligament of Treitz - in patients with type 2 diabetes mellitus (T2DM). The goal is to induce mucosal remodeling in this duodenal segment, potentially enhancing gut hormone signaling and improving glycemic control. Participants will be monitored for changes in HbA1c, fasting glucose, and insulin sensitivity over 6-12 months.
详细描述
The duodenum is a key site of nutrient sensing and hormonal regulation, and duodenal dysfunction contributes to the pathophysiology of type 2 diabetes mellitus (T2DM).
This single-center prospective pilot study investigates Endoscopic Band Ligation (ENDOBAND-DM) targeting the second through fourth parts of the duodenum, beginning just distal to the ampulla of Vater and extending to the ligament of Treitz.
The endoscopic application of elastic bands is designed to induce localized mucosal changes in the duodenum, potentially modulating enteroendocrine responses such as GLP-1 and GIP secretion and improving insulin sensitivity.
Adult participants with suboptimally controlled T2DM (HbA1c 7.5-10.5%) who are not on insulin therapy will undergo a single EBL session. Follow-up will occur at 1, 3, 6, and 12 months post-intervention.
Primary outcome: Change in HbA1c at 6 months. Secondary outcomes include changes in fasting glucose, insulin resistance indices (e.g., HOMA-IR), gut hormones, weight, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Confirmed diagnosis of type 2 diabetes mellitus
- •HbA1c between 7.5% and 10.5% at screening
- •Body Mass Index (BMI) between 27 and 40 kg/m²
- •Stable use of oral antidiabetic medications for ≥3 months prior to enrollment
- •Willingness to undergo endoscopic procedure and attend all follow-up visits
- •Signed informed consen
排除标准
- •Use of insulin therapy
- •Previous bariatric or gastrointestinal surgery
- •Diagnosis of type 1 diabetes mellitus
- •Known gastrointestinal obstruction, ulcers, or active GI bleeding
- •History of pancreatitis, biliary disease, or abnormal anatomy in duodenum
- •Pregnancy or breastfeeding
- •Severe comorbidities (e.g., uncontrolled cardiovascular disease, advanced kidney or liver disease)
- •Use of GLP-1 receptor agonists within 3 months prior to enrollment
- •Inability or unwillingness to comply with the study protocol
研究组 & 干预措施
ENDOBAND-DM
Participants in this arm will undergo endoscopic band ligation (ENDOBAND-DM) targeting the second through fourth parts of the duodenum, from just distal to the ampulla of Vater to the ligament of Treitz. The procedure is designed to induce localized mucosal changes that may enhance enteroendocrine signaling (e.g., GLP-1, GIP) and improve glycemic control in patients with type 2 diabetes mellitus.
干预措施: Endoscopic Band Ligation (ENDOBAND-DM) (Procedure)
结局指标
主要结局
Change in HbA1c level from baseline
时间窗: Baseline and 6 months post-intervention
Mean change in glycosylated hemoglobin (HbA1c) will be measured at 6 months after the endoscopic band ligation procedure, compared to baseline values. This will assess the primary glycemic effect of the intervention.
次要结局
- Change in fasting plasma glucose(Baseline and 6 months)
研究者
Mohamed Abeid
Consultant Gastroenterologist and Bariatric Endoscopist, Cairo University
Cairo University