Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Sodium Bicarbonate
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
干预措施: Sodium bicarbonate (Drug)
Placebo
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
时间窗: 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
次要结局
- Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)(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)(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(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)(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(The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.)