Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT06886087
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
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:
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 All adverse events will be recorded from Visit 2 until the subject completes or is withdrawn from the study.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:
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:
6.5 Visit 3
This visit will take place approximately 6 months after the donor nephrectomy. During this visit, the study team will:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
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.
Time frame: 12 months
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
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Prospective Study to Assess the Risks of Perinephric Fat Thickness on Adverse Renal Outcomes Post Donor Nephrectomy - ProActive Study
Acronym: ProActive
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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