The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Compare change in gastric acid output in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet.
研究概览
简要总结
The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.
详细描述
The calcium sensing receptor (CaSR) was originally found on parathyroid and renal cells and more recently it has been identified on cells that regulate gastric acid secretion (G cells and parietal cells). However, its role in regulating acid secretion in humans is completely unknown and is of potential importance because an acid environment in the stomach enhances intestinal calcium absorption. In this pilot project, we will stimulate the CaSR with a CaSR-agonist called cinacalcet. Our hypothesis is that activation of the CaSR will in turn increase gastric acid production in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy ambulatory men and postmenopausal women
- •Age 45 to 70
- •Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.
排除标准
- •Ionized Ca++ level <4.39 mg/dl or >5.02 mg/dl (normal reference range 4.18- 5.02).
- •24-hour UCa++ excretion >350 mg.
- •AST/ALT values >10% beyond reference range.
- •Hgb level <11.7 g/dl in women and <13.2 g/dl in men.
- •MCV level >102 UM
- •Basal acid output >5 mEq/h in men and >3.8 mEq/h in women.
- •Basal acid output <1 mEq/h in men and <0.2 mEq/h in women.
- •Age <45 or >
- •Premenopausal or <1 year post-menopause.
- •Individuals following vegan diets.
- •Current EtOH abuse.
- •Lidocaine allergy. Medications
- •H2 blockers
- •Proton pump inhibitors
- •Anticholinergic agents (i.e. TCA)
- •Cholinergic agents
- •Antihistamines in the last 3 weeks
- •Adrenergic blockers
- •Thiazide diuretics
- •Antiplatelet drugs
- •Oral and Inhaled Glucocorticoids
- •Bisphosphonates
- •Raloxifene, Tamoxifen
- •EtOH during study
- •Calcitonin
- •Ketoconazole/Itraconazole
- •Calcitriol
- •Paricalcitol
- •Drisdol, Ergocalciferol
- •Phosphate binders
- •Anticoagulant
- •Erythromycin
- •Hormone replacement therapy except vaginal estrogen creams
- •Exclusion Diseases
- •Achlorhydria
- •Pernicious anemia
- •Zollinger Ellison syndrome
- •Congestive heart failure
- •Esophageal strictures or motility problems
- •History of a GI bleed
- •Prior upper GI surgery
- •Malabsorption
- •History of GI malignancy
- •GERD, gastritis, duodenitis
- •Active peptic ulcer disease
- •Gallbladder disease
- •Liver disease
- •Pancreatitis
- •Current kidney stone
- •Renal disease
- 另有 5 项未显示
结局指标
主要结局
Compare change in gastric acid output in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet.
时间窗: 11 days
次要结局
- Compare serum gastrin levels in subjects before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet.(11 days)
- Compare 24-hour urinary calcium excretion before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet.(11 days)
- Compare serum IGF-1 levels before and after an 11-day course of cinacalcet or placebo and on a fixed protein metabolic diet.(11 days)
- Compare change in urinary magnesium excretion in response to an 11-day course of daily cinacalcet or placebo in subjects on a fixed protein metabolic diet.(11 days)