The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.
Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
Urinary TGF-b1 is considered a marker of renal fibrosis
Time frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.
Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
KIM-1 is a marker of of kidney injury.
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
NGAL is a marker of kidney injury
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Levels of Fibronectin
Fibronectin is a marker of kidney injury.
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Albumin Levels
Urinary albumin is a marker of kidney damage
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Estimated Glomerular Filtration (eGFR)
eGFR is a measure of kidney function
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
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