The proposed studies will examine the effect of fisetin on adipose tissue-derived mesenchymal stem/stromal cell function, kidney function, markers of inflammation, and physical function in individuals with advanced chronic kidney disease.
The proposed studies will examine the effect of fisetin on adipose tissue-derived mesenchymal stem/stromal cell function, kidney function, markers of inflammation, and physical function in individuals with advanced chronic kidney disease, particularly diabetic kidney disease. This study will involve a single 2-day oral treatment regimen with fisetin or placebo. Study subjects will be randomized 2:1 to study drug or placebo. Study visits will consist of blood, urine, and abdominal wall skin and subcutaneous fat samplings in addition to testing of physical strength at given time points. Subjects will be followed for a total of 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Flavonoid family
Placebo
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in inflammatory markers including C-reactive protein
To examine the effect of study drug (compared to placebo) on markers of inflammation in skin, fat, plasma, and urine measured at baseline and day 14
Time frame: 14 days
Effect on Mesenchymal stem cell function including cell migration
To examine the effect of study drug (compared to placebo) on mesenchymal stem cell function and vitality measured at baseline and day 14
Time frame: 14 days
Effect on measures of Frailty including Fried Criteria
To examine the effect of study drug (compared to placebo) on markers of physical frailty (frailty phenotype).
Time frame: 4 months
Kidney function including estimated glomerular filtration rate
To examine the effect of study drug (compared to placebo) on kidney function.
Time frame: 4 months
Kidney function including urine protein excretion rate
To examine the effect of study drug (compared to placebo) on kidney function protein excretion
Time frame: 4 months
Number of participants with treatment-related adverse events including hospitalization
To assess the safety and tolerability of study drug taken over two days (compared to placebo)
Time frame: 12 months
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