Safety and Efficacy of Chlorthalidone to Reduce Urinary Calcium Excretion in Adolescents/Yount Adult With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Urinary Calcium Excretion
研究概览
简要总结
This open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes
详细描述
Type 1 diabetes (T1D) is associated with increased urinary calcium loss, which may contribute to the low bone mineral density and increased fracture risk observed in patients with this condition. Chlorthalidone is a thiazide-like diuretic that is commonly used to reduce urinary calcium excretion in other conditions such as idiopathic hypercalciuria. Its safety and efficacy has not been specifically tested in an adolescent type 1 diabetes population.
T1D subjects with hypercalciuria and who meet inclusion/exclusion criteria will be given chlorthalidone daily. Blood and urine tests, blood pressure, and glycemic control will be assessed at weekly study visits for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T1D
- •Age 12-21 years
- •Tanner Stage 2 or greater pubertal development
- •Urine calcium excretion ≥ 4 mg/kg/day
- •Able to swallow pills
排除标准
- •BMI > 99th percentile for age (<18 years) or BMI >35 kg/m2 (≥ 18 years)
- •Coexistent conditions that may affect calcium metabolism including:
- •celiac disease
- •Graves' Disease
- •Addison's disease
- •hypo- or hyperparathyroidism
- •History of diabetes related complications including:
- •neuropathy
- •retinopathy
- •nephropathy
- •gastroparesis
- •History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month
- •History of any diuretic use within the past month
- •Laboratory abnormalities on screening bloodwork including:
- •estimated glomerular filtration rate <90 mL/min per 1.73 m2 of body surface area
- •serum calcium >10.5 mg/dL
- •serum potassium <3.5 mmol/L
- •Systolic or diastolic blood pressure <5th percentile for age and sex50 for age <18 years or systolic <90 mmHg or diastolic blood pressure <60 mmHG for age ≥18 years
研究组 & 干预措施
Chlorthalidone
Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks
干预措施: Chlorthalidone (Drug)
结局指标
主要结局
Urinary Calcium Excretion
时间窗: Assessed at baseline and at 4 weeks
Change in 24 hour urine calcium excretion
Hypercalcemia
时间窗: Assessed weekly for up to 4 weeks or until hypercalcemia develops
Serum calcium increased to \>10.5 mg/dL
Hypokalemia
时间窗: Assessed weekly for up to 4 weeks or until hypokalemia develops
Serum potassium decreased to \<3.5 milliequivalent/L
Hyperglycemia
时间窗: Assessed at baseline and at 4 weeks
Change in serum fructosamine
次要结局
未报告次要终点