Bariatric Surgery + Pancreas Transplant for Type 2 Diabetes
(ComB-PAK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for type 2 diabetes in individuals who have undergone a kidney transplant due to diabetic nephropathy (kidney damage caused by diabetes). The researchers aim to determine if combining a sleeve gastrectomy (a type of weight-loss surgery) with a pancreas transplant can control blood sugar without insulin and maintain the function of the transplanted kidney. Participants will be divided into two groups: one will undergo the surgeries at different times, while the other will have both simultaneously. Suitable candidates for this trial include those who had a kidney transplant at least six months ago, have a BMI over 30, and exhibit signs of metabolic syndrome, such as high blood pressure or high triglycerides. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations that could significantly improve health outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves surgery and transplantation, it's possible that some medication adjustments might be necessary. Please consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sleeve gastrectomy, a type of weight-loss surgery, is generally well-tolerated. Studies have found that it can improve diabetes and lead to significant weight loss. However, researchers are still studying its long-term safety, especially for people with type 2 diabetes. So far, no deaths have been directly linked to the procedure, which is reassuring.
For pancreas transplantation, results are usually positive. Research indicates good survival rates for both the patient and the new pancreas. This surgery often helps people with severe diabetes by improving blood sugar control and overall survival. However, it is a complex procedure, and like any major surgery, it carries risks.
In this trial, both treatments are combined. Each has its own safety record, suggesting they are generally safe, but the combination is still being explored.12345Why are researchers excited about this trial?
Researchers are excited about combining bariatric surgery with pancreas transplants for Type 2 Diabetes because it represents a novel dual approach to tackling the disease. Traditional treatments often include lifestyle changes, oral medications, and insulin therapy, but this innovative method aims to address the root causes by simultaneously managing weight and restoring insulin production. The staggered approach involves performing sleeve gastrectomy before pancreas transplantation, potentially allowing for initial weight loss and metabolic improvements before tackling insulin issues. Alternatively, the combined approach performs both procedures at once, offering a comprehensive treatment that could lead to significant improvements in glucose control and potentially long-term remission of diabetes. This dual strategy could offer new hope for patients who struggle to manage their diabetes with current therapies.
What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?
This trial will compare two approaches: a staggered approach and a combined approach. Research has shown that sleeve gastrectomy, which participants in this trial may undergo, can lead to significant weight loss and help some people with type 2 diabetes manage their blood sugar better. However, it might not be the best option for everyone with diabetes, as other surgeries like gastric bypass have demonstrated better long-term results. Conversely, receiving a new pancreas through a transplant, another treatment option in this trial, can improve blood sugar control and reduce the need for insulin in people with type 2 diabetes. Studies indicate that pancreas transplants can also help kidney transplants last longer in patients who receive both. Together, these treatments might offer a promising way to manage type 2 diabetes and improve overall health.34678
Who Is on the Research Team?
Trevor Reichman
Principal Investigator
University Health Network, Toronto
Are You a Good Fit for This Trial?
This trial is for adults with Type 2 Diabetes and obesity who've had a kidney transplant due to diabetic nephropathy. They should have a BMI over 30, be insulin-dependent for at least a year, and not smoke. Candidates must be at least six months post-kidney transplant surgery with stable kidney function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment (Staggered Approach)
Participants undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant
Treatment (Combined Approach)
Eligible participants undergo Sleeve Gastrectomy and pancreas transplantation simultaneously
Follow-up
Participants are monitored for safety and effectiveness after treatment, with data collection up to 1 year post PAK transplant
What Are the Treatments Tested in This Trial?
Interventions
- Pancreas after Kidney Transplantation
- Sleeve Gastrectomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor