The Laparoscopic Transit Bipartition Without Gastrectomy With Use Metalic Anastomosis Clip (MAC) for Treating Type 2 Diabetes Mellitus and Obesity
New surgery for Type 2 Diabetes and Obesity with novel clip device
Plain English Summary
The Laparoscopic Transit Bipartition With Use Metalic Anastomosis Clip is a Not Applicable clinical trial sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan studying Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic. This trial tests a new surgical technique called transit bipartition, using a novel metal clip, to treat Type 2 Diabetes and overweight/obesity. It is for adults aged 18-65 with Type 2 Diabetes and a BMI between 25 and 35, who are not currently eligible for standard bariatric surgery. Participants will be randomly assigned to one of three surgical methods: the new metal clip, hand-sewn stitches, or a stapler. Alternatives include lifestyle changes, medications like GLP-1 agonists, and existing bariatric surgeries for those with higher BMIs. The trial aims to enroll 90 participants.
Official Summary
This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²). Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients fall below this threshold and cannot access surgical treatment under existing guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation. The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs. Participants will be randomised into three groups: MAC-assisted anastomosis, hand-sewn anastomosis, or stapled anastomosis. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have Type 2 Diabetes and a Body Mass Index (BMI) between 25 and 35. You cannot join if you have diabetes that requires insulin, are under 18 or over 65, have had stomach surgery before, have a psychiatric illness, or cannot give consent. The study is looking for patients with Type 2 Diabetes and overweight or Class I obesity. This trial is studying Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures will show if the surgery helps patients achieve remission of Type 2 Diabetes and how safe the surgical connection (anastomosis) is, meaning it will tell us if the diabetes The specific primary outcome measures are: T2DM remission rate (Baseline, 1, 2, 3 year after surgery); Anastomotic complication rate (<30 day after surgery, 1, 2, 3 year after surgery). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a gap in treatment by offering a surgical option for Type 2 Diabetes and obesity in patients with lower BMIs, who are often excluded from current bariatric surgery guidelines. This research targets Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic, where improved treatment options are needed.
Investor Insight
This trial explores a new device for a procedure targeting a significant patient population with Type 2 Diabetes and obesity, potentially offering a cost-effective and safer alternative to existing me
Is This Trial Right for Me?
Ask your doctor if this surgical approach is right for you, especially if you have Type 2 Diabetes and a BMI between 25-35. Participation involves surgery and follow-up visits over several years to monitor your diabetes, weight, and overall health. You will be randomly assigned to one of three surgical techniques, and your progress will be tracked through regular check-ups. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 90 participants
Interventions
- PROCEDURE: laparoscopic transit bipartition with Metallic Anastomotic Clip — laparoscopic transit bipartition with bypass gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip
- PROCEDURE: laparoscopic transit bipartition using manual suture anastomosis — laparoscopic transit bipartition using manual suture anastomosis
- PROCEDURE: laparoscopic transit bipartition using mechanical stapled anastomosis — laparoscopic transit bipartition using mechanical stapled anastomosis
Primary Outcomes
- T2DM remission rate (Baseline, 1, 2, 3 year after surgery)
- Anastomotic complication rate (<30 day after surgery, 1, 2, 3 year after surgery)
Secondary Outcomes
- Change of body mass index (Baseline, 1, 2, 3 year after surgery)
Full Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of Type 2 Diabetes Mellitus * BMI 25-35 kg/m2 Exclusion Criteria: * Insulin dependent diabetes * BMI \<25 and \>35 kg/m2 * History of surgery on the stomach * Less than 18 or more than 65 years of age * Psychiatric illness * Patients unwilling or unable to provide informed consent
Frequently Asked Questions
What is clinical trial NCT07495020?
NCT07495020 is a Not Applicable INTERVENTIONAL study titled "The Laparoscopic Transit Bipartition With Use Metalic Anastomosis Clip." It is currently not yet recruiting and is sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan. The trial targets enrollment of 90 participants.
What conditions does NCT07495020 study?
This trial investigates treatments for Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic. The primary condition under study is Type 2 Diabetes Mellitus (T2DM).
What treatments are being tested in NCT07495020?
The interventions being studied include: laparoscopic transit bipartition with Metallic Anastomotic Clip (PROCEDURE), laparoscopic transit bipartition using manual suture anastomosis (PROCEDURE), laparoscopic transit bipartition using mechanical stapled anastomosis (PROCEDURE). laparoscopic transit bipartition with bypass gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip
What does Not Applicable mean for NCT07495020?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07495020?
This trial is currently "Not Yet Recruiting." It started on 2026-03-25. The estimated completion date is 2028-05-30.
Who is sponsoring NCT07495020?
NCT07495020 is sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07495020?
The trial aims to enroll 90 participants. The trial has not yet started recruiting.
How is NCT07495020 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07495020?
The primary outcome measures are: T2DM remission rate (Baseline, 1, 2, 3 year after surgery); Anastomotic complication rate (<30 day after surgery, 1, 2, 3 year after surgery). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07495020?
The official record for NCT07495020 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07495020. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07495020 testing in simple terms?
This trial tests a new surgical technique called transit bipartition, using a novel metal clip, to treat Type 2 Diabetes and overweight/obesity. It is for adults aged 18-65 with Type 2 Diabetes and a BMI between 25 and 35, who are not currently eligible for standard bariatric surgery.
Why is this trial significant?
This trial addresses a gap in treatment by offering a surgical option for Type 2 Diabetes and obesity in patients with lower BMIs, who are often excluded from current bariatric surgery guidelines.
What are the potential risks of participating in NCT07495020?
Potential risks include complications from surgery, such as leaks at the surgical connection site, bleeding, or the development of ulcers near the connection. Other side effects could involve issues related to the digestive system, though the new clip aims to reduce some of these risks compared to traditional methods. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07495020?
Ask your doctor if this surgical approach is right for you, especially if you have Type 2 Diabetes and a BMI between 25-35. Participation involves surgery and follow-up visits over several years to monitor your diabetes, weight, and overall health. You will be randomly assigned to one of three surgical techniques, and your progress will be tracked through regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07495020 signal from an investment perspective?
This trial explores a new device for a procedure targeting a significant patient population with Type 2 Diabetes and obesity, potentially offering a cost-effective and safer alternative to existing me This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to one of three surgical methods: the new metal clip, hand-sewn stitches, or a stapler. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Type 2 Diabetes Mellitus (T2DM) Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.