Type 2 DiabetesNCT05692518
MagDI Diversion Feasibility Study
A study testing MAGNET System, DI Bio-fragmentable in people with Type 2 Diabetes and Obesity, run by GT Metabolic Solutions, Inc. at 1 site in Georgia.
Trial summary
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- MAGNET System, DI Bio-fragmentable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGeorgia
- Study dates
- 19 Dec 2022to 20 May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age, inclusive, at the time of informed consent
- BMI 30-35 kg/m2
- Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
- If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
- Willing and able to comply with protocol requirements
Who cannot join
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled T2DM
- Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
- Uncontrolled hypertension, dyslipidemia or sleep apnea
- Prior intestinal, colonic or duodenal surgery, other than bariatric
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- Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
- Refractory gastro-esophageal reflux disease (GERD)
- Barrett's disease
- Helicobacter pylori positive and/or active ulcer disease
- Large hiatal hernia
- Inflammatory bowel or colonic diverticulitis disease
- Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
- Implantable pacemaker or defibrillator
- Psychiatric disorder, except well-controlled depression with medication for > 6 mo
- History of substance abuse
- Woman who is either pregnant or breast feeding
- Woman of childbearing potential who does not agree to use an effective method of contraception.
- Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure.
- Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures
- Had surgical or interventional procedure within 30 days prior to procedure
- Any scheduled surgical or interventional procedure planned within 30 days post-procedure
- Any stroke/transient ischemic attack (TIA) within 6 months prior to consent
- Requires chronic anticoagulation therapy (except aspirin)
- Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
- Unable to comply with the follow-up schedule and assessments
- Recent tobacco or nicotine product cessation within < 3 months prior to informed consent
- Known allergies to the device components or contrast media
- Limited life expectancy due to terminal disease
- Currently participating in another clinical research study with an investigational drug or medical device
- A positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19) test prior to the study procedure in accordance with local COVID-19 protocol
- Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.
Read the detailed description
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- MAGNET System, DI Bio-fragmentable
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGNET System, DI Bio-fragmentableDevice
Anastomoses achieved by magnetic compression.
| Study group | Role | What they receive |
|---|---|---|
| MAGNET System, DI Bio-fragmentable | Experimental | GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System Receives: Device: MAGNET System, DI Bio-fragmentable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a patent anastomosis
Confirmed radiologically or fluoroscopically
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start19 Dec 2022
- Primary completion23 Aug 2024
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, open-label, single-arm, feasibility device study.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GT Metabolic Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692518
- Sponsor's protocol ID
- GTM-005
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05692518
- Acronym / sponsor ID
- GTM-005
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 20 Jan 2023 (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 purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.
Detailed description
The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, open-label, single-arm, feasibility device study.
| Arm | Type | Receives |
|---|---|---|
| MAGNET System, DI Bio-fragmentable | Experimental | Device: MAGNET System, DI Bio-fragmentableGT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years of age, inclusive, at the time of informed consent
- BMI 30-35 kg/m2
- Type 2 diabetes mellitus (T2DM), defined as HbA1c > 6.5%, without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
- If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
Key exclusion criteria (32 listed)
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled T2DM
- Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
- Uncontrolled hypertension, dyslipidemia or sleep apnea
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 |
|---|---|---|
| MAGNET System, DI Bio-fragmentableAnastomoses achieved by magnetic compression. | Device | MAGNET System, DI Bio-fragmentable |
Primary outcome
Creation of a patent anastomosis
Time frame: 30 Days
Confirmed radiologically or fluoroscopically
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGNET System, DI Bio-fragmentable in people with Type 2 Diabetes and Obesity, run by GT Metabolic Solutions, Inc. at 1 site in Georgia.
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 6 inclusion and 32 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a patent anastomosis (time frame: 30 Days). 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 23 Dec 2025.