NCT04067752Completed
Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease
Source: ClinicalTrials.gov · Last updated 8 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 19 Aug 2019
- Start date
- 1 Mar 2022
- Primary completion date
- 15 May 2024
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Chronic kidney disease
- NCT number
- NCT04067752
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 1 Mar 2022 to the primary completion date, 15 May 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intolerance to the medication in metabolic studies)
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer or cancer history in the prior 5 years, HIV, liver disease, active chronic hepatitis B or C)
- Type 1 Diabetes on insulin therapy; Hospitalization within 1 month prior to the study
- Receiving steroids (including inhaled steroid and high potency topical, with the exception of over the counter hydrocortisone cream
Other
- Pregnancy
- Presence of a metal object in the body that might interfere with MRI
- Prednisone \> 5 mg/day) and/or other immunosuppressive agents
- Residual renal function \> 5ml/min or urine output \> 400 ml/day
Who the study is looking for
- On MHD for more than 6 months
- Have acceptable dialysis adequacy (eKt/V \> 1.2) for a minimum of 3 months and a patent, well-functioning, hemodialysis AV access
- Ability to give informed consent
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.