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Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression

Not Applicable
Completed
Conditions
Kidney Diseases, Chronic
Dietary Modification
Registration Number
NCT03202914
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
840
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Serum metabolomic profile12 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health

🇺🇸

Baltimore, Maryland, United States

Johns Hopkins Bloomberg School of Public Health
🇺🇸Baltimore, Maryland, United States

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