Type 2 Diabetes MellitusDMR-IBF-GMNCT06385704
Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR)
A study testing DMR Procedure in people with Type 2 Diabetes Mellitus, run by Wang Siqi.
Trial summary
The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DMR Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.25-65 years of age. 2.Diagnosed with type 2 diabetes. 3.Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol). 4.Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2. 5.Currently taking one or more oral glucose lowering medications, with no changes in dose or medication in the previous 12 Weeks prior to study entry.
- 6.Able to comply with study requirements and understand and sign the informed consent.
Who cannot join
- Clinical diagnosis of type 1 diabetes.
- Current use of Glucagon-like peptide-1 (GLP-1) analogues.
- Hypoglycemia unawareness or a history of severe hypoglycemia.
- Clinical diagnosis of autoimmune disease.
- Previous gastrointestinal surgery that could affect the ability to treat the duodenum.
- Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure.
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- Clinical diagnosis of anemia.
- Not potential candidates for surgery or general anesthesia.
- Participating in another ongoing clinical trial of an investigational drug or device.
- Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
Trial locations and contacts
No sites are listed yet.
Hua Meng, Doctor contact
About this study
Official title: Changes in Intestinal Barrier Function and Gut Microbiome After Duodenal Mucosal Resurfacing
The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiotic analysis and High Performance Liquid Chromatography (HPLC), combined with changes in clinical data.
Read the detailed description
This study aims to enroll 100 patients diagnosed with type 2 diabetes who have suboptimal control with one or more oral antidiabetic drugs. Of these, 50 will receive DMR treatment at the Metabolic Weight Loss Center of the China-Japan Friendship Hospital and will be followed up, while the other 50, who have not received DMR treatment, will be matched by age and gender for comparison. Each patient or their legal guardian will sign an informed consent form to participate in the study. Researchers will be granted access to the patients' medical records and will collect their medical history and treatment data. Researchers will also collect urine and fecal samples for microbiome analysis，metagenomics-based studies and HPLC, analyzing the changes in intestinal barrier function and gut microbiota before and after DMR treatment, and between DMR-treated and non-DMR-treated patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DMR Procedure
- Keywords
- Type 2 Diabetes Mellitus, Duodenal Mucosal Resurfacing, Intestinal Barrier Function, Gut Microbiome
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMR ProcedureProcedure or surgery
Endoscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| DMR Procedure | Experimental | Subjects receive the endoscopic DMR procedure in this arm Receives: Procedure: DMR Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Analysis
Characterization of of gut microbiome using next generation sequencing technology
Measured: one week and one month post-treatment
High Performance Liquid Chromatography
Intestinal barrier function using HPLC technology
Measured: one week and one month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Siqi
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor-investigator, Wang Siqi, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385704
- Sponsor's protocol ID
- DMRIBFGM0420
- Acronym
- DMR-IBF-GM
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Intestinal Barrier Function and Gut Microbiome After Duodenal Mucosal Resurfacing
- ClinicalTrials.gov ID
- NCT06385704
- Acronym / sponsor ID
- DMR-IBF-GM / DMRIBFGM0420
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Duodenal Mucosal Resurfacing, Intestinal Barrier Function, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wang SiqiUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Apr 2024 (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.
The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiotic analysis and High Performance Liquid Chromatography (HPLC), combined with changes in clinical data.
Detailed description
This study aims to enroll 100 patients diagnosed with type 2 diabetes who have suboptimal control with one or more oral antidiabetic drugs. Of these, 50 will receive DMR treatment at the Metabolic Weight Loss Center of the China-Japan Friendship Hospital and will be followed up, while the other 50, who have not received DMR treatment, will be matched by age and gender for comparison. Each patient or their legal guardian will sign an informed consent form to participate in the study. Researchers will be granted access to the patients' medical records and will collect their medical history and treatment data. Researchers will also collect urine and fecal samples for microbiome analysis，metagenomics-based studies and HPLC, analyzing the changes in intestinal barrier function and gut microbiota before and after DMR treatment, and between DMR-treated and non-DMR-treated patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMR Procedure | Experimental | Procedure: DMR ProcedureSubjects receive the endoscopic DMR procedure in this arm |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.25-65 years of age. 2.Diagnosed with type 2 diabetes. 3.Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol). 4.Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2. 5.Currently taking one or more oral glucose lowering medications, with no changes in dose or medication in the previous 12 Weeks prior to study entry.
- 6.Able to comply with study requirements and understand and sign the informed consent.
Key exclusion criteria (10 listed)
- Clinical diagnosis of type 1 diabetes.
- Current use of Glucagon-like peptide-1 (GLP-1) analogues.
- Hypoglycemia unawareness or a history of severe hypoglycemia.
- Clinical diagnosis of autoimmune disease.
- Previous gastrointestinal surgery that could affect the ability to treat the 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 |
|---|---|---|
| DMR ProcedureEndoscopic procedure | Procedure or surgery | DMR Procedure |
Primary outcome
Microbiome Analysis
Time frame: one week and one month post-treatment
Characterization of of gut microbiome using next generation sequencing technology
High Performance Liquid Chromatography
Time frame: one week and one month post-treatment
Intestinal barrier function using HPLC technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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. This study is not recruiting at the moment.
Hua Meng, Doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing DMR Procedure in people with Type 2 Diabetes Mellitus, run by Wang Siqi.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact siqi Wang, Doctor (+8618810315722, rjzd280@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Analysis (time frame: one week and one month post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.