Bariatric Surgery + Pancreas Transplant for Type 2 Diabetes

(ComB-PAK Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Smoking, Peripheral vascular disease, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness of sleeve gastrectomy combined with pancreas after kidney (PAK) transplantation as a means of achieving normoglycemia, insulin independence, reduced insulin resistance, and kidney graft function preservation in the T2DM population. in the first year post pancreas after kidney transplant. Safety and efficacy data will be collected from the time of enrollment until participants reach 1 year post PAK transplant. Data will be compared to historical data from TGH's renal and pancreas transplant programs.

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.

What data supports the effectiveness of the treatment Bariatric Surgery + Pancreas Transplant for Type 2 Diabetes?

Research shows that combined kidney and pancreas transplantation is effective for managing diabetes-related kidney disease, with improved outcomes due to advancements in surgical techniques and patient care. Additionally, pancreas transplants can normalize blood sugar levels and improve diabetic complications, although the specific impact on survival beyond kidney transplant alone is debated. ^{1 2 3 4 5}

Is pancreas transplantation generally safe for humans?

Pancreas transplantation can have a high rate of surgical complications, such as fistulas (abnormal connections between organs), graft thromboses (blood clots in the transplanted organ), and intra-abdominal abscesses (pockets of pus). However, patient survival rates and graft function rates are generally excellent, and quality of life often improves significantly after a successful transplant. ^{6 7 8 9 10}

How is the treatment of bariatric surgery combined with pancreas transplant unique for type 2 diabetes?

This treatment is unique because it combines bariatric surgery, specifically sleeve gastrectomy, with a pancreas transplant, which is not a standard approach for type 2 diabetes. Sleeve gastrectomy helps with weight loss and improves blood sugar control, while the pancreas transplant aims to restore insulin production, potentially offering a more comprehensive solution for managing diabetes. ^{11 12 13 14 15}

Research Team

Trevor Reichman

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

It has been at least 6 months since my kidney transplant surgery.

You have at least three out of four specific health conditions related to metabolism.

Willing and able to provide informed consent

Exclusion Criteria

I do not have any health issues that would make the SG procedure unsafe for me.

My kidney function is reduced.

I have had weight loss surgery in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment (Staggered Approach)

Participants undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant

3 months

Treatment (Combined Approach)

Eligible participants undergo Sleeve Gastrectomy and pancreas transplantation simultaneously

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection up to 1 year post PAK transplant

12 months

Treatment Details

Interventions

• Pancreas after Kidney Transplantation
• Sleeve Gastrectomy

Trial Overview The study tests if sleeve gastrectomy (a weight loss surgery) combined with pancreas transplantation can control blood sugar levels, reduce the need for insulin, improve resistance to insulin, and preserve kidney graft function in patients after their first year of pancreas after kidney transplant.

Participant Groups

Group I: Group 2: Combined Approach Experimental Treatment 1 Intervention

Eligible participants will undergo SG and pancreas transplantation simultaneously

Group II: Group 1: Staggered Approach Experimental Treatment 1 Intervention

The first 10 participants enrolled will undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 6062 patients who underwent laparoscopic sleeve gastrectomy (LSG), type 2 diabetics (T2DM) showed no increased risk of 30-day complications compared to non-diabetic patients, indicating that LSG is a safe option for this population.

While T2DM patients had a slightly higher rate of blood transfusions post-surgery, the overall complication rate was similar to non-diabetics, and type 1 diabetics experienced higher complication rates than both T2DM and non-diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of laparoscopic sleeve gastrectomy among diabetic patients. Creange, C., Sethi, M., Fielding, G., et al.[2018]

A systematic review of 27 studies involving 673 patients showed that laparoscopic sleeve gastrectomy (LSG) led to a significant resolution of type 2 diabetes mellitus (DM) in 66.2% of patients, with 26.9% experiencing improvement in their condition.

Patients had an average excess weight loss of 47.3% after LSG, and notable decreases in blood glucose levels (-88.2 mg/dL) and hemoglobin A1c (-1.7%) were observed, indicating LSG's potential as an effective metabolic therapy for type 2 DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy and type 2 diabetes mellitus: a systematic review. Gill, RS., Birch, DW., Shi, X., et al.[2022]

Laparoscopic sleeve gastrectomy is a highly effective and safe surgical option for treating obesity and type 2 diabetes mellitus, making it a popular choice in bariatric surgery.

The review highlights the significant efficacy of this procedure, indicating its growing acceptance and application in the field of metabolic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the application of laparoscopic sleeve gastrectomy in bariatric and metabolic surgery]. Xu, B., Yao, QY.[2018]

In a study of 35 patients with type 2 diabetes, both Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SLG) led to significant improvements in diabetes remission, with 13 patients from RYGB and 7 from SLG achieving remission.

Key factors for diabetes remission included baseline β-cell glucose sensitivity and an improved GLP-1 response after surgery, indicating that these hormonal changes are crucial for the effectiveness of the surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. Nannipieri, M., Baldi, S., Mari, A., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Kidney-pancreas transplants: is it so difficult to start a program? [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Simultaneous kidney-pancreas transplantation. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Pancreas outcomes between living and deceased kidney donor in pancreas after kidney transplantation patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Combined kidney and pancreas transplantation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative risk evaluation: where is the limit for recipients of a pancreatic graft? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Surgical complications are the main cause of pancreatic allograft loss in pancreas-kidney transplant recipients. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

High levels of C-reactive protein after simultaneous pancreas-kidney transplantation predict pancreas graft-related complications and graft survival. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes of simultaneous pancreas-kidney transplantation in type 2 diabetic recipients. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Intestinal obstruction due to internal hernia following pancreas transplantation. [2015]

10. Germany pubmed.ncbi.nlm.nih.gov

[Risk and benefits of pancreas transplantation]. [2008]

11. Germany pubmed.ncbi.nlm.nih.gov

The safety of laparoscopic sleeve gastrectomy among diabetic patients. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy and type 2 diabetes mellitus: a systematic review. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

[Comparative efficacy of three bariatric surgery procedures in obese patients with type 2 diabetes]. [2018]

14. China pubmed.ncbi.nlm.nih.gov

[Evaluation of the application of laparoscopic sleeve gastrectomy in bariatric and metabolic surgery]. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Roux-en-Y gastric bypass and sleeve gastrectomy: mechanisms of diabetes remission and role of gut hormones. [2013]