Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

Diabetes Mellitus Clinical Trial

Official title:

Investigations of the Optimum Serum Bicarbonate Level in Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574157
• Other study ID #: CLIN-002-11F
• Status: Completed
• Phase: N/A
• Start date: November 5, 2012
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran

• Age older than 18 years

• Diabetes mellitus

• Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months

• Stage 2, 3, or 4 CKD (defined as estimated glomerular filtration rate (eGFR) 15 - 89 ml/min/1.73m2 using the CKD-Epidemiology equation)

• Urinary albumin:creatinine ratio > 30 mg/gm on the most recent sample within the past 12 months.

Exclusion Criteria:

• Lean body weight > 100 kg

• Use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate).

• Serum potassium < 3.5 meq/L at enrollment visit

• Use of 5 or more antihypertensive agents, regardless of the indications of each agent

• Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at the enrollment or baseline visit

• Diagnosis of congestive heart failure with current, active Class III or IV New York Heart Association symptoms.

• Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial

• chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)

• Chronic immunosuppressive therapy for transplanted organs or other indications

• Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).

11.Currently participating in another interventional research study

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Diabetes Mellitus
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium bicarbonate
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)	Urinary TGF-b1 is considered a marker of renal fibrosis	The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.
Secondary	Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)	KIM-1 is a marker of of kidney injury.	The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Secondary	Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)	NGAL is a marker of kidney injury	The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Secondary	Change in Urinary Levels of Fibronectin	Fibronectin is a marker of kidney injury.	The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Secondary	Change in Urinary Albumin Levels	Urinary albumin is a marker of kidney damage	The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Secondary	Change in Estimated Glomerular Filtration (eGFR)	eGFR is a measure of kidney function	The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.