Assessment of Risks of Perinephric Fat Thickness to Adverse Renal Outcomes Post Donor Nephrectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants in this study will be restricted to living kidney transplant donors (LKDs). .

Disqualifiers

Those who do not meet Mayo Clinic Rochester's clinical criterion for donor nephrectomy.

>10% weight change between the donor evaluation and donor nephrectomy

Individuals who are pregnant or are planning to become pregnant

Inability to comply with study procedures or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study.

Trial population

Living kidney donors scheduled for nephrectomy ages 18 - 80

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Non-Obese
Group B: Obese

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.