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Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression

NCT ID: NCT03202914

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

1988-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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).

Conditions

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Dietary Modification Kidney Diseases, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Usual protein and phosphorus diet

protein: 1.3 g/kg/day, phosphorus: 16-20 mg/kg/day

Group Type ACTIVE_COMPARATOR

Usual protein and phosphorus diet

Intervention Type BEHAVIORAL

Diet intervention

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

Group Type ACTIVE_COMPARATOR

Low protein and phosphorus diet

Intervention Type BEHAVIORAL

Diet intervention

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)

Group Type EXPERIMENTAL

Very low protein and phosphorus

Intervention Type BEHAVIORAL

Diet intervention

Interventions

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Usual protein and phosphorus diet

Diet intervention

Intervention Type BEHAVIORAL

Low protein and phosphorus diet

Diet intervention

Intervention Type BEHAVIORAL

Very low protein and phosphorus

Diet intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Casey M. Rebholz, PhD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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. 1996 May;27(5):652-63. doi: 10.1016/s0272-6386(96)90099-2.

Reference Type RESULT
PMID: 8629624 (View on PubMed)

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. 1994 Mar 31;330(13):877-84. doi: 10.1056/NEJM199403313301301.

Reference Type RESULT
PMID: 8114857 (View on PubMed)

Rebholz CM, Zheng Z, Grams ME, Appel LJ, Sarnak MJ, Inker LA, Levey AS, Coresh J. Serum metabolites associated with dietary protein intake: results from the Modification of Diet in Renal Disease (MDRD) randomized clinical trial. Am J Clin Nutr. 2019 Mar 1;109(3):517-525. doi: 10.1093/ajcn/nqy202.

Reference Type DERIVED
PMID: 30753252 (View on PubMed)

Other Identifiers

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K01DK107782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00007383

Identifier Type: -

Identifier Source: org_study_id