Status:
COMPLETED
Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief 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-energ...
Detailed Description
There are more than 420,000 patients receiving maintenance hemodialysis therapy in the United States, which is estimated to rise to over 500,000 patients by 2020. There are an estimated 45,500 Veteran...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnancy
- Intolerance to the medication in metabolic studies)
- Presence of a metal object in the body that might interfere with MRI
- 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
- Prednisone \> 5 mg/day) and/or other immunosuppressive agents
- Residual renal function \> 5ml/min or urine output \> 400 ml/day
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04067752
Start Date
March 1 2022
End Date
May 20 2024
Last Update
November 8 2024
Active Locations (2)
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1
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
2
Vanderbilt University Medical center
Nashville, Tennessee, United States, 37232