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NCT04067752 · ClinicalTrials.gov registry record · NA
Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT04067752: Completed NA study, sponsored by VA Office of Research and Development.
NCT04067752 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04067752, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
By 2030 an estimated 2 million people in the US will need dialysis or transplantation. Insulin resistance and chronic inflammation are common in dialysis patients and have been linked to protein-energy wasting, the most important determinant of clinical outcome in this patient population. The investigators hypothesize that the skin and muscle tissue sodium accumulation is a critical mechanism by which chronic inflammatory response and insulin resistance, alone or in combination lead to protein energy wasting in hemodialysis patients. The investigators will test this hypothesis by studying dialysis patients and matched controls without kidney disease by examining tissue Na content, markers of inflammation and protein metabolism.
Primary Outcome
Net whole-body muscle protein balance measured by stable isotope technique reported as mg/kg.fat free mass/min. This reflects the balance between endogenous leucine appearance rate (protein synthesis), the leucine oxidation rate, and the non-oxidative leucine disappearance rate (protein breakdown).
Interventions
- OTHER high dialysate sodium concentration (138 mEq/L)
- OTHER Low dialysate sodium concentration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2024-05-20 |
| Phase | NA |
What the finished NCT04067752 record still lists
NCT04067752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which high dialysate sodium concentration (138 mEq/L) is the first listed.
NCT04067752 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04067752 about?
NCT04067752 is a clinical study titled "Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease". By 2030 an estimated 2 million people in the US will need dialysis or transplantation. Insulin resistance and chronic inflammation are common in dialysis patients and have been linked to protein-energy wasting, the most important determinant of clinical outcome in this patient population. The invest...
What is the current status of trial NCT04067752?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2022-03-01. Estimated completion is 2024-05-20.
What interventions are being tested in trial NCT04067752?
The interventions under investigation include: high dialysate sodium concentration (138 mEq/L) (OTHER), Low dialysate sodium concentration (OTHER).
Who is sponsoring clinical trial NCT04067752?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04067752's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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