Dietary Modification, Kidney Diseases, Chronic
Conditions
Brief summary
The present record represents a secondary data analysis of the Modification of Diet in Renal Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of dietary intake as well as biomarkers of kidney disease progression.
Detailed description
The present study was conducted in order to: 1) quantify the metabolomic expression of dietary intake; and 2) examine the relationship between metabolites that reflect dietary intake and kidney disease progression. This secondary data analysis leverages the completed Modification of Diet in Renal Disease (MDRD) study, a randomized clinical trial of dietary protein restriction (N=840).
Interventions
BEHAVIORALUsual protein and phosphorus diet
Diet intervention
BEHAVIORALLow protein and phosphorus diet
Diet intervention
BEHAVIORALVery low protein and phosphorus
Diet intervention
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tufts Medical Center
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
During the original MDRD Study, clinical center personnel as well as study participants were masked to the results of the outcome assessment during the follow-up period.
Intervention model description
The present study consists of a secondary data analysis of the MDRD Study. Planned analyses will be limited to participants with available stored specimens. The original MDRD Study was a 2 x 2 factorial study design, in which individuals were randomized to amounts of protein and phosphorus intake and levels of blood pressure control. In this secondary data analysis, we will analyze metabolites according to level of protein intake and will adjust for the blood pressure intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 * Evidence of chronic renal disease with increased serum creatinine (men: 1.4-7.0 mg/dL, women: 1.2-7.0 mg/dL) * Mean arterial blood pressure less than or equal to 125 mmHg
Exclusion criteria
* Insulin-dependent diabetes * Kidney transplant recipient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum metabolomic profile | 12 month follow-up visit | Metabolites were measured using a global, untargeted, metabolomic platform in serum specimens collected at the 12 month follow-up visit in the MDRD Study. Reverse phase, untargeted ultra-performance liquid chromatography tandem mass spectrometry quantification was used to measure metabolites. Peaks were quantified by calculating the area under the curve. Data were normalized to account for day-to-day instrumental variation. Compounds were identified by comparison to a library of purified standards or recurrent unknown entities and matches were determined based on retention time, mass-to-charge ratio, and chromatographic data. |
Countries
United States
Outcome results
None listed