Vascular Risk After Kidney Transplantation

NCT00374595 | Completed Results DMC

• 2 other identifiers: 0053-95-FB1R01DK069919-01A2
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease; Chronic Kidney Disease; Diabetes; Vitamin D Deficiency; Hyperparathyroidism

Keywords

Kidney Transplant; Vascular Risk; inflammation; Diabetes; Insulin resistance; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Transplant Clinic patients

You may qualify if:

• Kidney transplant more than 6 months ago
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Vitamin D Deficiency; Hyperparathyroidism; Inflammation; Insulin Resistance

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Parathyroid Diseases; Hyperinsulinism

Results Point of Contact

• Title: Jennifer Larsen
• Organization: University of Nebraska Medical Center

jlarsen@unmc.edu

(402) 559-4837

Study Officials

• Jennifer L Larsen, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: April 1, 2006
• Primary Completion: July 26, 2012
• Study Completion: June 20, 2023
• Last Updated: October 2, 2023
• Results First Posted: August 9, 2023

Record last verified: 2023-09

Locations

US (1)