Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression

Not Applicable

Completed

• Conditions: Kidney Diseases, Chronic; Dietary Modification
• Interventions: Behavioral: Low protein and phosphorus diet; Behavioral: Very low protein and phosphorus; Behavioral: Usual protein and phosphorus diet

• 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).

Study Timeline

• Study Start: 1988-10
• Primary Completion: 1993-05
• Study Completion: 2016-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Study First Posted: 2017-06-29
• Last Update Posted: 2017-06-29

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

Arm && Interventions

Group	Intervention	Description
Low protein and phosphorus diet	Low protein and phosphorus diet	protein: 0.58 g/kg/day with ≥0.35 g of protein high in amino acids, phosphorus: 5-10 mg/kg/day
Very low protein and phosphorus	Very low protein and phosphorus	protein: 0.28 g/kg/day, phosphorus: 4-9 mg/kg/day; keto-acid and amino acid supplement (0.28 g/kg/day)
Usual protein and phosphorus diet	Usual protein and phosphorus diet	protein: 1.3 g/kg/day, phosphorus: 16-20 mg/kg/day

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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