The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.
The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.
Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.
This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •age 65 year and older
- •Type 2 diabetes
排除标准
- •less than 65 years of age
研究组 & 干预措施
Acarbose
Acarbose 50mg by mouth at minute 0 of the Meal Test.
干预措施: Acarbose (Drug)
Placebo
Placebo 1 tablet at 0 minutes of Meal Test.
干预措施: Placebo (Drug)
结局指标
主要结局
Heart rate
时间窗: continuously during Meal Test; about 4 hours
Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours
Blood pressure
时间窗: Continuously during Meal Tests (approximately 4 hours)
Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)
Middle cerebral artery velocity
时间窗: continuously during Meal Tests (approximately 4 hours)
Middle cerebral artery velocity will be measure continuously by transcranial doppler during the Meal Tests (approximately 4 hours)
Serum glucose
时间窗: Every 15 minutes during Meal Tests
Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer
Serum insulin
时间窗: Every 15 minutes during Meal Tests (approximately 4 hours)
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide)
时间窗: Every 15 minutes during Meal Tests (approximately 4 hours)
Serum peptides will be collected every 15 minutes for the duration of the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Catecholamines
时间窗: Continuously during Meal Test (approximately 4 hours)
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
次要结局
未报告次要终点
研究者
Kenneth Madden
Principal Investigator
University of British Columbia