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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
Minimum 6 months post-Kidney transplantation surgery
Insulin dependent >1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3,6, 9 and 12
Awards & highlights

ComB-PAK Trial 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.Check my eligibility
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.See study design
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.

ComB-PAK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been at least 6 months since my kidney transplant surgery.
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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.

ComB-PAK Trial 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

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

ComB-PAK 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
1,456 Previous Clinical Trials
482,779 Total Patients Enrolled
13 Trials studying Obesity
937 Patients Enrolled for Obesity
Trevor ReichmanPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Pancreas after Kidney Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT05576116 — N/A
Obesity Research Study Groups: Group 1: Staggered Approach, Group 2: Combined Approach
Obesity 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can sign up for this medical study?

"This trial has a narrow set of eligibility criteria, recruiting only those aged 18 to 50 who are overweight. A total of 20 people will be taking part in the study."

Answered by AI

Is the age eligibility for this clinical trial limited to individuals over 25 years of age?

"Meeting the prerequisites for this investigation, persons of 18 years or older and no more than 50 are eligible to take part."

Answered by AI

Is it possible for new participants to join this trial currently?

"According to clinicaltrials.gov, this particular trial has ceased recruitment as of October 20th 2022; however, there are currently 1089 other trials actively seeking patients."

Answered by AI
~12 spots leftby Jun 2026