Effects of Insulin on Hypotension and Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia
详细描述
Diabetes is common in the elderly. By the age of 70, approximately 25% of the population has diabetes and another 25% is at risk for diabetes. Elderly patients with diabetes are at increased risk for disability and reduction in their instrumental and basic activities of daily living. The prevalence of frailty is higher in people with diabetes that with age matched controls without diabetes. One of the major contributing factors to frailty is sarcopenia.
Insulin is an important anabolic hormone that prevents protein breakdown and to a lesser extent stimulates protein synthesis. There is some evidence that the ability of insulin to stimulate anabolic processes may be reduced in diabetes.
Insulin has cardiovascular properties, resulting in simultaneous adrenergic and vasodilatory responses that have opposing influences on blood pressure. Epidemiological studies have demonstrated that the use of insulin is a risk factor for syncope.
The investigators will study 30 older adults age 65 and older with type 2 diabetes who have never taken insulin to manage their diabetes but now need insulin to manage their diabetes. Data will be compared pre insulin start and 3 and 6 months after starting insulin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •65 years of age or older
- •Type 2 diabetes for at least 5 years
- •Insulin naive
- •now needs insulin to manage diabetes
排除标准
- •anemia as defined by serum hematocrit
- •abnormal liver function tests
- •elevated serum creatinine
- •smoked within last 5 years
- •musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals
- •aortic stenosis
研究组 & 干预措施
Type 2 Diabetes, Insulin Naive
Study participants will be tested prior to and 3 and 6 months after starting insulin to manage their diabetes
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Body composition
时间窗: Change from months 0, 3 and 6 months post insulin start
Measured by DEXA Scan
Grip strength
时间窗: Change from months 0, 3 and 6 months post insulin start
measured by Hand Dynamometer
Physical functioning Survey
时间窗: Change from months 0, 3 and 6 months post insulin start
measured by the Physical Component Summary from the SF-12 Health
Presence or absence of orthostatic hypotension
时间窗: Change from months 0, 3 and 6 months post insulin start
Drop in systolic blood pressure of greater than 20 mmHg after 3 minutes of standing
Nadir of systolic blood pressure during the Tilt Table Test
时间窗: Change from months 0, 3 and 6 months post insulin start
Lowest systolic blood pressure obtained during the Tilt Table Test
Nadir of diastolic blood pressure during the Tilt Table Test
时间窗: Change from months 0, 3 and 6 months post insulin start
Lowest diastolic blood pressure obtained during the Tilt Table Test
次要结局
- Nadir of middle cerebral artery velocity as measured by transcranial doppler(Change from months 0, 3 and 6 months post insulin start)
- Presence or absence of a positive Tilt Table Test (vasovagal syncope)(Change from months 0, 3 and 6 months post insulin start)
研究者
Kenneth Madden
Associate Professor, UBC Department of Medicine
University of British Columbia