Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Bicarbonate | Active Comparator | Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months |
|
| Placebo | Placebo Comparator | Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL) |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kalani L Raphael, MD | VA Salt Lake City Health Care System, Salt Lake City, UT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35369374 | Derived | Gardner J, Tuttle K, Raphael KL. Influence of Medications Containing Acid Salts on Serum Bicarbonate in CKD. Kidney360. 2020 Mar 31;1(5):330-336. doi: 10.34067/KID.0000532019. eCollection 2020 May 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were recruited from VA Salt Lake City Healthcare System from November 2012 to October 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Bicarbonate | Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months. |
| FG001 | Placebo | Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Bicarbonate | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) | Urinary TGF-b1 is considered a marker of renal fibrosis | Posted | Geometric Mean | 95% Confidence Interval | percent change | The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups. |
|
Adverse event data were collected during each participant's 6-month follow-up period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Bicarbonate | 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. |
Not provided
Not provided
Change in urinary levels of Bb and membrane attack complex (MAC) were initial secondary outcomes. However, we had difficulty measuring these. Many subjects could not complete the physical activity assessment, which was an initial secondary outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kalani Raphael, Principal Investigator | VA Salt Lake City Healthcare System | 801-582-1565 | 1794 | kalani.raphael@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2019 | Jun 11, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 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. |
|
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. |
| 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. |
| 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. |
| 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. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Estimated glomerular filtration rate | Mean | Standard Deviation | ml/min/1.73m2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Use of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin receptor blocker (ARB) | Count of Participants | Participants |
|
| Total body weight | Mean | Standard Deviation | kg |
|
| Lean body weight | Mean | Standard Deviation | kg |
|
| Congestive heart failure | Count of Participants | Participants |
|
| Serum total carbon dioxide (CO2) | Mean | Standard Deviation | meq/L |
|
| Serum potassium | Mean | Standard Deviation | meq/L |
|
| Hemoglobin A1c | Mean | Standard Deviation | % |
|
| Urinary albumin/creatinine | Median | Inter-Quartile Range | mg/g |
|
| Urinary pH | Mean | Standard Deviation | units on a scale |
|
| Urinary ammonium | Mean | Standard Deviation | meq/d |
|
| Urinary titratable acids | Mean | Standard Deviation | meq/d |
|
| Urinary transforming growth factor-B1/creatinine | Median | Inter-Quartile Range | ng/g |
|
| Urinary kidney injury molecule-1/creatinine | Median | Inter-Quartile Range | ng/mg |
|
| Urinary fibronectin/creatinine | Median | Inter-Quartile Range | ng/mg |
|
| Urinary neutrophil gelatinase-associated lipocalin/creatinine | Median | Inter-Quartile Range | ng/mg |
|
|
|
|
| Secondary | Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1) | KIM-1 is a marker of of kidney injury. | Posted | Mean | 95% Confidence Interval | percent change | 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 | Posted | Geometric Mean | 95% Confidence Interval | percent change | 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. | Posted | Geometric Mean | 95% Confidence Interval | percent change | 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 | Posted | Geometric Mean | 95% Confidence Interval | percent change | 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 | Posted | Mean | 95% Confidence Interval | ml/min per 1.73m2 | The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups. |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | 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. | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |