Type 2 Diabetes Mellitus (T2DM)ENDOBAND-DMNCT07117721
Endoscopic Band Ligation for Type 2 Diabetes Mellitus (ENDOBAND-DM)
A study testing Endoscopic Band Ligation (ENDOBAND-DM) in people with Type 2 Diabetes Mellitus (T2DM), run by El Katib Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Endoscopic Band Ligation (ENDOBAND-DM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Endoscopic Band Ligation for Treatment of Type 2 Diabetes: A Single-Center Interventional Study
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.
Read the 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)
- Being tested
- Endoscopic Band Ligation (ENDOBAND-DM)
- Keywords
- Endoscopic band ligation, Duodenal intervention, Metabolic endoscopy, GLP-1, GIP, Insulin resistance, HbA1c, Non-surgical diabetes treatment, Duodenal mucosal modulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Band Ligation (ENDOBAND-DM)Procedure or surgery
Also called ENDOBAND - DM, Duodenal Banding
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic Band Ligation (ENDOBAND-DM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months post-intervention
Secondary outcomes (1)
Change in fasting plasma glucose
Measured in mg/dL to assess improvement in fasting glucose levels after intervention.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El Katib Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abeid, Cairo University
- Investigators
- Mohamed A. Abeid, MD, MSc, Principal investigator, Faculty of Medicine, Cairo Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117721
- Sponsor's protocol ID
- M.Abeid-ENDOBAND-DM-2025
- Acronym
- ENDOBAND-DM
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including baseline characteristics, intervention details, and outcome measures) will be shared with qualified researchers upon reasonable request, starting 12 months after study completion and for up to 5 years. Requests should be directed to mohamedabeid@gmail.com and will require a data access agreement.
Publications
Abeid M, Zaitoun N. Endoscopic Band Ligation for Weight Loss: A Clinical Trial. Obes Surg. 2025 Jan;35(1):280-284. doi: 10.1007/s11695-024-07609-3. Epub 2024 Dec 20.
PubMed 39707144
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Band Ligation for Treatment of Type 2 Diabetes: A Single-Center Interventional Study
- ClinicalTrials.gov ID
- NCT07117721
- Acronym / sponsor ID
- ENDOBAND-DM / M.Abeid-ENDOBAND-DM-2025
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Endoscopic band ligation, Duodenal intervention, Metabolic endoscopy, GLP-1, GIP, Insulin resistance, HbA1c, Non-surgical diabetes treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- El Katib HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ENDOBAND-DM | Experimental | Procedure: Endoscopic Band Ligation (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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Band Ligation (ENDOBAND-DM)Also: ENDOBAND - DM, Duodenal BandingEndoscopic 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. | Procedure or surgery | ENDOBAND-DM |
Primary outcome
Change in HbA1c level from baseline
Time frame: 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.
1 secondary outcome
Change in fasting plasma glucose
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 39707144Abeid M, Zaitoun N. Endoscopic Band Ligation for Weight Loss: A Clinical Trial. Obes Surg. 2025 Jan;35(1):280-284. doi: 10.1007/s11695-024-07609-3. Epub 2024 Dec 20.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including baseline characteristics, intervention details, and outcome measures) will be shared with qualified researchers upon reasonable request, starting 12 months after study completion and for up to 5 years. Requests should be directed to mohamedabeid@gmail.com and will require a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A. Abeid, MD, MSc principal investigator
Faculty of Medicine, Cairo Univesity
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Band Ligation (ENDOBAND-DM) in people with Type 2 Diabetes Mellitus (T2DM), run by El Katib Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A. Abeid, MD, MSc (+201001222254, mohamedabeid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c level from baseline (time frame: Baseline and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07117721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.