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

NCT ID: NCT07117721

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-01-01

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endoscopic Band Ligation (ENDOBAND-DM)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

ENDOBAND - DM; Duodenal Banding

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

El Katib Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abeid

Consultant Gastroenterologist and Bariatric Endoscopist, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A. Abeid, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Cairo Univesity

Central Contacts

Mohamed A. Abeid, MD, MSc

Role: CONTACT

mohamedabeid@gmail.com

+201001222254

References

Yli-Hankala A. [Is my patient sleeping?]. Duodecim. 1998;114(16):1563-9. No abstract available. Finnish.

Reference Type: BACKGROUND

PMID: 11717791 (View on PubMed)

Other Identifiers

M.Abeid-ENDOBAND-DM-2025

Identifier Type: -

Identifier Source: org_study_id