Vascular Risk After Kidney Transplantation

Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.

The purpose of this study is to evaluate which traditional and nontraditional cardiovascular disease risk factors best predict progression of cardiovascular disease (CVD) using carotid intima media thickness performed by ultrasound, in kidney transplant patients.

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Key information

Conditions

Cardiovascular Disease Avitaminosis Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Deficiency Diseases Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Hyperparathyroidism Inflammation Insulin Resistance Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

Cardiovascular disease remains the greatest cause of mortality after kidney transplant. Traditional risk factors, such as hypertension, diabetes, hyperlipidemia and smoking, contribute to vascular disease after transplant, but nontraditional risk factors may play a bigger role in vascular disease progression in this setting. This observational study will evaluate nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Kidney transplant more than 6 months ago
19 years or older

Exclusion criteria

Estimated GFR <30
Previous small bowel, or lung transplant
Pancreas transplant less than 6 months ago
Cancer or any condition that would change weight dramatically in the near future such as malabsorption.
Willing to return for testing annually for 3 years
Women who are pregnant

Treatment and study plan

Primary outcomes

Carotid Intima Media Thickness (CIMT)

Time frame: 3 years (baseline and three year follow up)

CIMT was defined by ultrasound. The mean and standard error of a 3 year change in CIMT was assessed (between baseline and three year follow up).

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2023
First posted: Sep 11, 2006
Registry last updated: Oct 2, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed