Cardiovascular Disease, Chronic Kidney Disease, Diabetes, Hyperparathyroidism, Vitamin D Deficiency
Conditions
Keywords
Kidney Transplant, Vascular Risk, inflammation, Diabetes, Insulin resistance, Chronic kidney disease
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.
Detailed 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
Interventions
None listed
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Nebraska
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima Media Thickness (CIMT) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kidney Transplant Recipients This observational study evaluated 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. | 338 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 23 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | relocation | 3 |
| Overall Study | too much time commitment | 1 |
| Overall Study | transfer care to other clinical site | 1 |
| Overall Study | Withdrawal by Subject | 39 |
Baseline characteristics
| Characteristic | Kidney Transplant Recipients |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 325 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 300 Participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 338 |
| other Total, other adverse events | 0 / 338 |
| serious Total, serious adverse events | 0 / 338 |
Outcome results
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).
Time frame: 3 years (baseline and three year follow up)
Population: 264 participants had 3 year follow-up for Carotid intima media thickness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kidney Transplant Recipients | Carotid Intima Media Thickness (CIMT) | 0.044 millimeters (mm) | Standard Error 0.006 |