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.
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
+5 more
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.
+4 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Group 2: Combined ApproachExperimental Treatment1 Intervention
Eligible participants will undergo SG and pancreas transplantation simultaneously
Group II: Group 1: Staggered ApproachExperimental Treatment1 Intervention
The first 10 participants enrolled will undergo Sleeve Gastrectomy a minimum of 3 months prior to Pancreas Transplant.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto General HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor