Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 1. Presence or absence of orthostatic hypotension
研究概览
简要总结
In the proposed study, the investigators examine in older adults with Type 2 diabetes the impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the response of arterial blood pressure and Doppler measures of cerebral blood flow during upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not present at baseline.
详细描述
Before and 2 weeks after the start of standard insulin therapy several tests will be done:
- orthostatic hypotension will be tested for with 3 orthostatic maneuvers
- vasovagal syncope will be tested with 2 tilt table tests, one augmented with 400ug of nitroglycerin
- MCA velocity will be measured with a transcranial doppler
- Heart Rate and Blood Pressure will be measured throughout the test with a Finometer and Power Lab on a beat to beat basis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All subjects must be 65 years of age or older
- •All must have been diagnosed with Type 2 diabetes for at least 5 years
- •All subjects must be insulin-naïve on recruitment
- •All subjects must be eligible to start insulin therapy (long or intermediate acting) as determined by their diabetologist
排除标准
- •Anemia, as determined by serum hematocrit
- •Abnormal liver function tests
- •Elevated creatinine
- •Musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals
研究组 & 干预措施
Before Initiation of Insulin Therapy
Study sessions will occur before the initiation of insulin therapy (no insulin). Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.
干预措施: No Insulin (Other)
After Initiation of Insulin Therapy
Study session will take place 2-4 weeks after the initiation of insulin therapy. Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.
干预措施: Insulin (Other)
结局指标
主要结局
1. Presence or absence of orthostatic hypotension
时间窗: 1 day
defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
次要结局
- 3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.(1 day)
- 1. The nadir of middle cerebral artery (MCA) velocity(1 day)
- 2. The presence or absence of a positive augmented tilt table test(1 day)
研究者
Kenneth Madden
Principal Investigator
University of British Columbia