Acarbose and Older Adults With Postprandial Hypotension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH
研究概览
简要总结
The current proposal will determine if blocking carbohydrate intake in the small intestine with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension (a drop of blood pressure after eating), which can result in falls.
详细描述
Blocking the absorption of carbohydrates at the brush border of the small intestine with acarbose (an alpha-glucosidase inhibitor) seems a promising possibility as a potential therapeutic agent. Although designed as a second-line diabetes drug, this medication has very little risk of hypoglycemia in older adults. In fact the risk of hypoglycemia is extremely low even in patients concurrently taking concurrent hypoglycemia agents (including insulin), and there is almost no risk of hypoglycemia in subjects not on other diabetes medications. Acarbose suppresses postprandial glycemia by slowing small intestinal digestion and absorption of carbohydrate, and has been shown to slow gastric emptying Acarbose has yet to be examined in a prospective fashion in older adults, despite the prevalence of PPH in this patient population. Preliminary, pilot work done in our laboratory on older adults with PPH has demonstrated that the hypotensive response over 90 minutes to a standardized meal was significantly reduced by the administration of acarbose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 65 years of age or older,
- •be a non-smoker for at least 5 years
- •be referred to the falls clinic at Vancouver General Hospital
- •have a Folstein test of cognition > 25/30 to ensure meal log-book compliance
排除标准
- •no oral or swallowing issues that would prevent a Meal Test
- •subject requiring dialysis due to end-stage renal failure will be excluded
- •subjects with evidence on history, physical or blood work of hepatic disease will be excluded since elevated serum transaminases are a potential adverse effect of acarbose
- •cannot currently be taking an alpha-glucosidase inhibitor
- •cannot have had allergic reactions to alpha-glucosidase inhibitors in the past
- •Due to the fact that acarbose is renally excreted, all subjects must have a Creatine Clearance of greater than 25 ml/min
- •Subjects with a past history of inflammatory bowel disease, intestinal obstruction, ileus and peptic ulcer disease will be excluded
- •Subjects taking carbohydrate-splitting enzymes (such as amylase) will be excluded
- •Subjects with chronic respiratory issues requiring treatment will be excluded
研究组 & 干预措施
Placebo
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension (PPH). At second Meal Test subject will receive a placebo and will take a placebo with the first bite of the next 3 meals.
干预措施: Placebo (Drug)
Acarbose
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension. During the second Meal Test subject will receive Acarbose 50mg and will take Acarbose 25mg with first bite of each of the next 3 meals.
干预措施: Acarbose (Drug)
结局指标
主要结局
The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH
时间窗: 2 years
The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal will be compared between n=30 subjects with PPH and n= 30 subjects without PPH.
次要结局
- The postprandial glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP) response to a standardized meal compared between subjects with and without PPH(2 years)
- The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared.(2.5 years)
研究者
Kenneth Madden
Division Head, VGH Division of Geriatric Medicine
University of British Columbia