VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148, United States
NCT Number: NCT01574157
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84148, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
11.Currently participating in another interventional research study
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.
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.
Urinary TGF-b1 is considered a marker of renal fibrosis
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
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.
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.
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.
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.
eGFR is a measure of kidney function
VA Office of Research and Development
Fed
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
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