Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
NCT05576116 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2022-10-24
Summary
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.
Conditions
- Diabetes Mellitus, Type 2
- Overweight
Interventions
- PROCEDURE
-
Sleeve Gastrectomy AND Pancreas after Kidney Transplantation (Staggered Approach)
Participants will undergo sleeve gastrectomy a minimum of 3 months prior to Pancreas Transplant. SG will be performed using the standard technique. Pancreas transplant will be performed as per standard procedure.
- PROCEDURE
-
Combined Sleeve Gastrectomy and Pancreas transplantation
Simultaneous SG and pancreas transplantation
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Trevor Reichman · University Health Network, Toronto
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-23
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- Canada
Study Locations
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