Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
This study explores a new way to treat Type 2 diabetes in people who have already had a kidney transplant due to their diabetes. We're investigating if combining a type of stomach reduction surgery, called a "sleeve gastrectomy," with a new pancreas transplant can help them achieve healthy blood sugar levels without needing insulin. The main aim is to understand if this approach can also protect the newly transplanted kidney from being damaged by diabetes in the long run. We'll be collecting information on how safe and effective this combination treatment is for one year after the pancreas transplant, and comparing it to what we already know from past treatments at Toronto General Hospital.
At a glance
What is this study about?
Diabetes is a major cause of kidney problems, and unfortunately, many people with diabetes eventually need a kidney transplant. While a new kidney can restore kidney function, it doesn't cure the underlying diabetes that caused the kidney failure in the first place. This means that even with a healthy new kidney, individuals with diabetes remain at risk for other serious health issues like heart problems, eye damage, nerve damage, and even damage to their new kidney.
Controlling blood sugar very carefully is key to preventing these problems, but it can be very difficult for many people with Type 2 diabetes, especially those who are overweight and have resistance to insulin. A pancreas transplant can be a game-changer because it allows the body to make its own insulin, often leading to normal blood sugar levels without the need for insulin injections. However, pancreas transplants are not usually offered to overweight people with Type 2 diabetes because it's thought they might still need insulin even after the transplant.
This study is looking at whether combining a specific weight-loss surgery, called a "sleeve gastrectomy," with a new pancreas transplant can make a real difference for people with Type 2 diabetes who have already received a kidney transplant. The idea is that weight loss can improve sensitivity to insulin, making the pancreas transplant more successful. Researchers want to see if this combined approach can help people stop taking insulin, achieve healthy blood sugar levels, and protect their transplanted kidney from further diabetes-related problems for at least one year after the pancreas transplant.
Key takeaways
- Tests a new approach for Type 2 diabetes in kidney transplant patients.
- Combines stomach reduction surgery (sleeve gastrectomy) with a new pancreas.
- Aims for normal blood sugar without insulin and to protect the new kidney.
- Study lasts for one year after pancreas transplant to track progress.
- May offer a significant improvement for overweight Type 2 diabetics with kidney transplants.
- Explores the link between weight loss and transplant success.
Who may be eligible?
To be considered for this study, you would need to be between 18 and 50 years old and have already received a kidney transplant because of Type 2 diabetes. At least six months should have passed since your kidney transplant. You also need to be overweight (with a body mass index, or BMI, over 30) and show signs of metabolic syndrome, which includes things like a large waist size and unhealthy levels of fats in your blood.
Additionally, you must have been taking insulin for more than a year and show some natural insulin production. If you are a woman, you must be past menopause, have had a procedure to prevent pregnancy, or be using effective birth control during the study. You cannot participate if you have poor kidney function with your transplanted kidney, have certain blood vessel problems, or have had bariatric surgery before. Smoking tobacco products is also not allowed, though occasional use of cannabis might be permitted.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 50 years old?
- Have you already had a kidney transplant because of Type 2 diabetes?
- Has it been at least 6 months since your kidney transplant?
- Are you currently overweight (BMI over 30)?
- Have you been taking insulin for more than a year?
- Have you *not* had weight-loss surgery before?
What does participation involve?
If you decide to take part in this study, the research team will explain everything to you in detail. You'll undergo either a sleeve gastrectomy (a surgery to make your stomach smaller) and then a pancreas transplant, or both surgeries at the same time. After the pancreas transplant, the team will closely monitor your health for one year. This will involve regular visits to the hospital or clinic for check-ups, blood tests, and other assessments to see how your body is responding to the treatments. They will be looking at things like your blood sugar levels, insulin use, and how well your new kidney is working. The total duration of active follow-up for this study will be one year after your pancreas transplant.
Potential risks and benefits
Locations (1)
- Toronto General HospitalVerified postcodeToronto, Canada
Common questions
What is a 'sleeve gastrectomy'?
It's a type of weight-loss surgery where a large part of your stomach is removed, leaving a smaller, banana-shaped stomach. This helps you feel full faster and eat less.
What is a 'pancreas after kidney transplant'?
This means you would receive a new pancreas transplant after you've already had a kidney transplant. The new pancreas helps your body produce its own insulin.
Why combine these two treatments?
The study is looking to see if losing weight through sleeve gastrectomy can make the pancreas transplant more effective, especially for people with Type 2 diabetes who are overweight and have resistance to insulin, helping them stop insulin and protect their kidney.
Will I still need diabetes medicine if I get a new pancreas?
The goal of a successful pancreas transplant is to help your body make its own insulin, potentially eliminating the need for insulin injections and other diabetes medications. However, you will need anti-rejection medicines.
How long will I be followed in this study?
Researchers will closely monitor your health for one year after your pancreas transplant to see how you are doing and how well the treatments are working.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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