NCT07117721

Endoscopic Band Ligation for Type 2 Diabetes Mellitus (ENDOBAND-DM)

Evaluation of Endoscopic Band Ligation for Treatment of Type 2 Diabetes: A Single-Center Interventional Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: El Katib Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. This study introduces a novel endoscopic approach aimed at duodenal mucosal modulation for metabolic benefit in type 2 diabetes.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Band Ligation (ENDOBAND-DM)	Endoscopic band ligation of the second through fourth parts of the duodenum, from just distal to the ampulla of Vater to the ligament of Treitz. The aim is to induce localized mucosal remodeling that may enhance enteroendocrine signaling (GLP-1, GIP) and improve glycemic control in patients with type 2 diabetes mellitus.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-08-12
• Last updated: 2025-08-15