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Bariatric Surgery + Pancreas Transplant for Type 2 Diabetes (ComB-PAK Trial)

N/A
Waitlist Available
Led By Trevor Reichman
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Insulin dependent >1 year
Females must be post-menopausal, surgically sterile or practicing adequate birth control for the duration of the study period
Must not have
eGFR < 60
Previous bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3,6, 9 and 12
Awards & highlights
No Placebo-Only Group

Summary

This trial evaluates if a combination of sleeve gastrectomy and pancreas after kidney (PAK) transplant can help diabetes patients achieve normal blood sugar, reduce insulin resistance, and preserve kidney function. Data will be collected over 1 year.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include surgical complications like infections or bleeding, issues related to organ rejection such as inflammation or failure of the new pancreas, changes in digestion or nutrient absorption from the stomach reduction surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been using insulin for more than a year.
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I am post-menopausal, surgically sterile, or using reliable birth control.
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I received a kidney transplant because of kidney damage from diabetes.
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My BMI is over 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is reduced.
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I have had weight loss surgery in the past.
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My blood vessels are healthy enough for a pancreas transplant.
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I have kidney damage from a BK virus infection or significant damage to my kidney transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3,6, 9 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3,6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patients achieving normoglycemia
Secondary study objectives
Body mass index (BMI)
Body Weight Changes
Change in body weight (kg) from baseline to post-PAK
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,224 Total Patients Enrolled
Trevor ReichmanPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Pancreas after Kidney Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT05576116 — N/A
Type 2 Diabetes Research Study Groups: Group 1: Staggered Approach, Group 2: Combined Approach
Type 2 Diabetes Clinical Trial 2023: Pancreas after Kidney Transplantation Highlights & Side Effects. Trial Name: NCT05576116 — N/A
Pancreas after Kidney Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05576116 — N/A
~8 spots leftby Jun 2026
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