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The goal of this observational study is to learn if PRAT thickness is a marker of visceral obesity and its influence on donors' kidney function and blood pressure in living kidney donors. Population includes male/female, 18 years and up, living kidney donors scheduled for nephrectomy within 6 months. The main area it aims to help in, is future care managing blood pressure and obesity in living kidney transplant donors.
Primary Hypothesis: We hypothesize that Perirenal Fat Thickness (PRAT) may exhibit expansion, remodeling and inflammation that can negatively affect renal outcomes in LKDs.
Researchers will compare PRAT morphology and inflammation in LKDs with low and high PRAT thickness.
We will also correlate PRAT thickness with renal outcomes including vascular remodeling, at the time of donation and worsening hypertension and inadequately increased compensatory GFR of the LKD at 4-6 months post-donation.
Participants will be separated into one of two groups depending on their PRAT measurement and asked to give samples of their blood, perinephric fat, and urine as research samples. Clinically we will abstract data up to 12 months prior and 6 months after their nephrectomy that includes laboratory findings, CT measurements, vitals, exam data, demographics, medical history and current medications.
6.1 Screening Visit Patients who have had their donor nephrectomy scheduled will be approached for enrollment. Potential participants must preliminarily meet all inclusion and no exclusion criteria to be approached by a study team member about study participation. If there is 10% (or greater) weight loss between the clinical donor evaluation visit and the potential screening visit the individual will not be approached for enrollment.
If all required inclusion and no exclusion criterion are met, the study team will present the consent form to the potential participant.
After the consent form has been signed, the following study procedures will be performed at the screening visit:
The following information will be collected study team member will review the participant's demographic information, m The following information will be recorded from the participant's from their electronic medical record
The following lab results will also be collected from the medical record
An 18-hour ABPM may be completed with subject consent at either the Screening Visit or Visit 1 if (if it has not been obtained clinically 6 months prior to the scheduled donor nephrectomy) or there has been a clinically significant blood pressure medication changes. A sphygmomanometry measurement will be collected at each visit unless the 18-hour ABPM is performed.
Serious adverse events will also be recorded and addressed as applicable at every study visit after the participant signs consent. All adverse events will be recorded from Visit 2 until the subject completes or is withdrawn from the study.
In applicable situations (i.e., the subject does not need to be seen in person to complete all study procedures) the screening visit can be completed remotely.
After this information has been collected, participants will be categorized into 1 of the 2 groups based upon their PRAT measurement and BMI. If the PRAT thickness or the BMI does not meet study criterion, the participant will be considered a screen failure.
6.2 Visit 1
During this visit, the following study procedures will also occur:
The study team will record the following information from the medical record:
10 mL of blood and 50mL urine will also be collected for research purposes.
An optional 18-hour ABPM may be completed if the subject has consented to this procedure and it was not collected during the screening visit. If a subject declines the 18-hour ABPM a sphygmomanometry measurement will be collected.
6.3 Visit 2
Visit 2 will occur the day of the living kidney donor's nephrectomy. During this visit, the study team will perform the following:
Record the following information from the participant's medical record:
During the nephrectomy, the study team will collect a 5-10g fat sample for research analysis.
6.5 Visit 3
This visit will take place approximately 6 months after the donor nephrectomy. During this visit, the study team will:
Record the following information from the EMR:
An 18-hour APBM will be completed with participant consent and if it was not completed as a part of clinical care. If a subject declines the 18-hour ABPM a 6h AMBP monitoring performed clinically will be collected
10 mL of blood and 50 mL of urine will be collected for research purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Obese | Participants with a BMI under 30 | ||
| Obese | Participants with a BMI greater than or equal to 30 |
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| Measure | Description | Time Frame |
|---|---|---|
| Proinflammatory Macrophage infiltrations of Perinephric Fat for LKD | Compare Living Kidney Donors total PRAT thickness with incidence of increased macrophages between the two groups in the study reported as a ratio between proinflammatory and anti-inflammatory and calculated to a percentage. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Development of new or worsening hypertension in LKD | Compare Living Kidney Donors total PRAT thickness with incidence of new or worsening hypertension as defined by a blood pressure of >140/90 mm Hg | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Living kidney donors scheduled for nephrectomy ages 18 - 80
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jackie Reiter | Contact | 507-538-2224 | reiter.jacqulyn@mayo.edu | |
| Maulik Lathiya, MBBS | Contact | lathiya.maulik@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Kukla, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35483987 | Background | Benavides X, Rogers RT, Tan EK, Merzkani MA, Thirunavukkarasu S, Yigitbilek F, Smith BH, Rule AD, Kukla A, Chow GK, Heimbach JK, Taner T, Dean PG, Prieto M, Stegall MD. Complications After Hand-Assisted Laparoscopic Living Donor Nephrectomy. Mayo Clin Proc. 2022 May;97(5):894-904. doi: 10.1016/j.mayocp.2021.11.023. Epub 2022 Apr 25. | |
| 23137211 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Blood, fat and urine
| Taler SJ, Messersmith EE, Leichtman AB, Gillespie BW, Kew CE, Stegall MD, Merion RM, Matas AJ, Ibrahim HN; RELIVE Study Group. Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades. Am J Transplant. 2013 Feb;13(2):390-8. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8. |
| 26888476 | Background | Ibrahim HN, Foley RN, Reule SA, Spong R, Kukla A, Issa N, Berglund DM, Sieger GK, Matas AJ. Renal Function Profile in White Kidney Donors: The First 4 Decades. J Am Soc Nephrol. 2016 Sep;27(9):2885-93. doi: 10.1681/ASN.2015091018. Epub 2016 Feb 17. |
| 31072668 | Background | Locke JE, Reed RD, Massie AB, MacLennan PA, Sawinski D, Kumar V, Snyder JJ, Carter AJ, Shelton BA, Mustian MN, Lewis CE, Segev DL. Obesity and long-term mortality risk among living kidney donors. Surgery. 2019 Aug;166(2):205-208. doi: 10.1016/j.surg.2019.03.016. Epub 2019 May 7. |
| 29498216 | Background | Sanchez OA, Ferrara LK, Rein S, Berglund D, Matas AJ, Ibrahim HN. Hypertension after kidney donation: Incidence, predictors, and correlates. Am J Transplant. 2018 Oct;18(10):2534-2543. doi: 10.1111/ajt.14713. Epub 2018 Apr 6. |
| 30053320 | Background | Issa N, Sanchez OA, Kukla A, Riad SM, Berglund DM, Ibrahim HN, Matas AJ. Weight gain after kidney donation: Association with increased risks of type 2 diabetes and hypertension. Clin Transplant. 2018 Sep;32(9):e13360. doi: 10.1111/ctr.13360. Epub 2018 Aug 18. |
| 33423338 | Background | Punjala SR, Adamjee Q, Silas L, Gokmen R, Karydis N. Weight trends in living kidney donors suggest predonation counselling alone lacks a sustainable effect on weight loss: a single centre cohort study. Transpl Int. 2021 Mar;34(3):514-524. doi: 10.1111/tri.13816. Epub 2021 Feb 3. |
| 30301366 | Background | Liu BX, Sun W, Kong XQ. Perirenal Fat: A Unique Fat Pad and Potential Target for Cardiovascular Disease. Angiology. 2019 Aug;70(7):584-593. doi: 10.1177/0003319718799967. Epub 2018 Oct 9. |
| 26417644 | Background | Ma S, Zhu XY, Eirin A, Woollard JR, Jordan KL, Tang H, Lerman A, Lerman LO. Perirenal Fat Promotes Renal Arterial Endothelial Dysfunction in Obese Swine through Tumor Necrosis Factor-alpha. J Urol. 2016 Apr;195(4 Pt 1):1152-9. doi: 10.1016/j.juro.2015.08.105. Epub 2015 Sep 28. |
| 12969157 | Background | Wang D, Iversen J, Wilcox CS, Strandgaard S. Endothelial dysfunction and reduced nitric oxide in resistance arteries in autosomal-dominant polycystic kidney disease. Kidney Int. 2003 Oct;64(4):1381-8. doi: 10.1046/j.1523-1755.2003.00236.x. |