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Metabolomics for Identifying Biomarkers of Dietary Intake and Kidney Disease Progression (MDRD)

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ClinicalTrials.gov Identifier: NCT03202914
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tufts Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dietary Modification Kidney Diseases, Chronic Behavioral: Usual protein and phosphorus diet Behavioral: Low protein and phosphorus diet Behavioral: Very low protein and phosphorus Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

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.
Primary Purpose: Prevention
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
Actual Study Start Date : October 1988
Actual Primary Completion Date : May 1993
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Phosphorus

Arm Intervention/treatment
Active Comparator: Usual protein and phosphorus diet
protein: 1.3 g/kg/day, phosphorus: 16-20 mg/kg/day
Behavioral: Usual protein and phosphorus diet
Diet intervention

Active Comparator: 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
Behavioral: Low protein and phosphorus diet
Diet intervention

Experimental: 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)
Behavioral: Very low protein and phosphorus
Diet intervention




Primary Outcome Measures :
  1. Serum metabolomic profile [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202914


Locations
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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tufts Medical Center
Investigators
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Principal Investigator: Casey M. Rebholz, PhD, MPH, MS Johns Hopkins Bloomberg School of Public Health
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03202914    
Other Study ID Numbers: IRB00007383
K01DK107782 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Disease Progression
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency