Vascular Risk After Kidney Transplantation

Diabetes Clinical Trial

Official title:

Vascular Risk After Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374595
• Other study ID #: 0053-95-FB
• Secondary ID: 1R01DK069919-01A
• Status: Completed
• Start date: April 2006
• Est. completion date: June 20, 2023

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: June 20, 2023
• Est. primary completion date: July 26, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Diabetes
• Hyperparathyroidism
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Intima Media Thickness (CIMT)	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).	3 years (baseline and three year follow up)