Prospective Study to Assess the Risks of Perinephric Fat Thickness on Adverse Renal Outcomes Post Donor Nephrectomy - ProActive Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proinflammatory Macrophage infiltrations of Perinephric Fat for LKD
研究概览
简要总结
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.
详细描述
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:
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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
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Participant's demographic information
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Medical history and current medications and, if needed, ask the participant clarifying questions
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Pregnancy test results (if applicable)
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Current medications
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Most recent weight
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Height
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BMI
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Clinical Donor Evaluation
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PRAT Measurement
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The following lab results will also be collected from the medical record
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in this study will be restricted to living kidney transplant donors (LKDs). .
排除标准
- •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.
研究组 & 干预措施
Non-Obese
Participants with a BMI under 30
Obese
Participants with a BMI greater than or equal to 30
结局指标
主要结局
Proinflammatory Macrophage infiltrations of Perinephric Fat for LKD
时间窗: 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.
次要结局
- Development of new or worsening hypertension in LKD(12 months)
研究者
Aleksandra Kukla
Consultant Nephrology
Mayo Clinic