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

NCT07117721 | Not Yet Recruiting

• 1 other identifier: M.Abeid-ENDOBAND-DM-2025
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Endoscopic band ligation; Duodenal intervention; Metabolic endoscopy; GLP-1; GIP; Insulin resistance; HbA1c; Non-surgical diabetes treatment; Duodenal mucosal modulation

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c level from baseline

  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.

  Baseline and 6 months post-intervention

Secondary Outcomes (1)

• Change in fasting plasma glucose

  Baseline and 6 months

Study Arms (1)

ENDOBAND-DM

EXPERIMENTAL

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.

Procedure: Endoscopic Band Ligation (ENDOBAND-DM)

Interventions

Endoscopic Band Ligation (ENDOBAND-DM) 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.

Also known as: ENDOBAND - DM, Duodenal Banding

ENDOBAND-DM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• El Katib Hospital: lead

Related Publications (1)

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

  PMID: 11717791 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Mohamed A. Abeid, MD, MSc

  Faculty of Medicine, Cairo Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A. Abeid, MD, MSc

CONTACT

+201001222254; mohamedabeid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist and Bariatric Endoscopist, Cairo University

Model Details: Single-center prospective pilot study. All enrolled participants will undergo endoscopic band ligation in the second through fourth parts of the duodenum and be followed for metabolic outcomes over 12 months.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share