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Bariatric Surgery + Pancreas Transplant for Type 2 Diabetes (ComB-PAK Trial)
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.
ComB-PAK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowComB-PAK Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ComB-PAK Trial Design
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Who is running the clinical trial?
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- 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.I have been using insulin for more than a year.I do not have any health issues that would make the SG procedure unsafe for me.I am post-menopausal, surgically sterile, or using reliable birth control.My kidney function is reduced.I have had weight loss surgery in the past.I smoke cigarettes, cigars, or pipes; I might occasionally smoke cannabis.My blood vessels are healthy enough for a pancreas transplant.I have kidney damage from a BK virus infection or significant damage to my kidney transplant.I received a kidney transplant because of kidney damage from diabetes.You have high fasting c-peptide levels because of type 2 diabetes.My BMI is over 30.Your albumin-to-creatinine ratio is higher than 2.9, indicating a potential kidney issue.
- Group 1: Group 1: Staggered Approach
- Group 2: Group 2: Combined Approach
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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