Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)
试验速览
- 阶段
- 3 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Urinary albumin creatinine ratio (ACR) measured biochemically
研究概览
简要总结
Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes mellitus. Diabetic nephropathy is caused by damage to the small blood vessels in the kidneys due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at filtering urine. This is associated with albuminuria (protein in the urine). Treatment with some drugs reduces the loss of albumin through the urine and delays disease progression. There is increasing evidence that vitamin D could also be important in management of diabetic kidney disease. The aim of this study is to investigate the efficacy and safety of a combined regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease.
详细描述
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in type 2 diabetes subjects with albuminuria. In the proposed study, the bioactive form of vitamin D (calcitriol) is being used for its ability to synergize with ACEI or ARB and prevent renal disease progression. The study expands on preliminary studies demonstrating a reduction in proteinuria with vitamin D analogue treatment, in subjects with both diabetic as well as non-diabetic kidney disease.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years and less than 80 years
- •Diagnosis of T2DM requiring treatment with at least one oral hypoglycaemic medication or insulin 2.
- •Subjects will be considered to have established T2DM if the diagnosis of diabetes has been made and the subjects were treated with insulin or an oral hypoglycaemic agent for at least 6 months after diagnosis 2.
- •Subjects will be considered to have newly established T2DM if the diagnosis of diabetes was diagnosed with a fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or haemoglobin A1c is >6.5% in the past 6 months
- •Documented albuminuria defined as a presence of albuminuria on two occasions in the last six months:
- •Albumin ≥ 30 mg/24 hour in a 24 hour urine collection, or 3.
- •Albumin ≥ 20 μg/min in a short-time urine collection, or 3.
- •Albumin ≥ 30 mg/L in a spot urine sample, or 3.
- •A spot-urine albumin-creatinine ration (ACR) ≥ 30 mg/g creatinine (≥ 2.5 mg/mmol creatinine in men, ≥ 3.5 mg/mmol creatinine in women)
- •Estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet in Renal Disease (MDRD) equation of ≥ 25 mL/min/1.73 m2
排除标准
- •If female, positive pregnancy test or planning pregnancy in the subsequent 12 months
- •Breastfeeding
- •Corrected serum calcium ≥ 2.62 mmol/L
- •Serum Potassium > 5.2 mmol/L if not on ACEI or ARB; Serum Potassium > 6.0 mmol/L if on ACEI or ARB
- •25-hydroxyvitamin D (25-OH Vit D) > 80 ng/mL
- •PTH > 200 pg/mL
- •Poorly controlled hypertension defined as systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg
- •Systolic blood pressure (SBP) ≤ 110 mm Hg
- •History of kidney stones
- •History of severe chronic disease (e.g. chronic liver disease)
- •Active malignancy
- •Recent diagnosis of acute renal failure within 3 months of screening visit
- •Likelihood of renal replacement therapy within 1 year
研究组 & 干预措施
Intervention Group
Participants are treated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks.
干预措施: Calcitriol (Drug)
结局指标
主要结局
Urinary albumin creatinine ratio (ACR) measured biochemically
时间窗: 26 weeks
Urine albumin and creatinine will be measured biochemically and their ratio calculated
次要结局
- 24-hour urine albumin (24h UA) excretion(26 weeks)
- Estimated glomerular filtration rate (eGFR)(26 weeks)
- Blood pressure(26 weeks)