Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression

Dietary Modification Clinical Trial

— MDRD  

Official title:

Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression: A Secondary Data Analysis of the Modification of Diet in Renal Disease (MDRD) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202914
• Other study ID #: IRB00007383
• Secondary ID: K01DK107782
• Status: Completed
• Phase: N/A
• First received: June 23, 2017
• Last updated: June 26, 2017
• Start date: October 1988
• Est. completion date: January 2016

Study information

• Verified date: June 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: January 2016
• Est. primary completion date: May 1993
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Dietary Modification
• Disease Progression
• Kidney Diseases
• Kidney Diseases, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Usual protein and phosphorus diet
Diet intervention
• Low protein and phosphorus diet
Diet intervention
• Very low protein and phosphorus
Diet intervention

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Klahr S, Levey AS, Beck GJ, Caggiula AW, Hunsicker L, Kusek JW, Striker G. The effects of dietary protein restriction and blood-pressure control on the progression of chronic renal disease. Modification of Diet in Renal Disease Study Group. N Engl J Med. — View Citation

Levey AS, Adler S, Caggiula AW, England BK, Greene T, Hunsicker LG, Kusek JW, Rogers NL, Teschan PE. Effects of dietary protein restriction on the progression of advanced renal disease in the Modification of Diet in Renal Disease Study. Am J Kidney Dis. 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum metabolomic profile	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.	12 month follow-up visit