Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Endoscopic band ligation, Duodenal intervention, Metabolic endoscopy, GLP-1, GIP, Insulin resistance, HbA1c, Non-surgical diabetes treatment, Duodenal mucosal modulation
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.
Interventions
PROCEDUREEndoscopic 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.
Sponsors
El Katib Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c level from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma glucose | Baseline and 6 months | Measured in mg/dL to assess improvement in fasting glucose levels after intervention. |
Contacts
CONTACTMohamed A. Abeid, MD, MSc
PRINCIPAL_INVESTIGATORMohamed A. Abeid, MD, MSc
Faculty of Medicine, Cairo Univesity
Outcome results
None listed