Cardiopulmonary Capacity In Different Quartiles Ranges Of Reference For Serum Thyroid Stimulating Hormone (TSH): Sectional Evaluation And Effect Of The Use Of Methimazole In Elderly Population
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlate in a population of more than 65 years old, the different levels of serum TSH, with cardiopulmonary capacity and these effects from baseline after treatment with antithyroid drugs
研究概览
简要总结
The purpose of this study is to correlate in an elderly population (≥ 65 years), the different levels of serum TSH, with cardiopulmonary capacity, quality of life, depressive symptoms and cognition. And assess whether the increased serum TSH to the upper half of the normal range, through the use of antithyroid drugs, is associated with improvements in these parameters.
详细描述
Specific Objectives:
Describe the cardiopulmonary capacity in elderly people with 65 years old or more, in different quartiles of normal range for serum TSH.
Assess the quality of life, mini mental health status and depression scale in seniors aged 65 or older, in different quartiles of normal range for serum TSH.
Quantify the possible effects related to the use of antithyroid drugs in cardiopulmonary capacity, quality of life, mini mental health status and depression scale in elderly people aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 milli-International unit/ml) (mIU/ml).
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •Age ≥ 65 years.
- •Healthy Men and women
- •Registration at the University Hospital Clementino Fraga Filho (HUCFF).
排除标准
- •Hypothalamic-pituitary disease
- •Congestive cardiac insufficiency, chronic renal failure, acute renal failure, stroke, chronic obstructive pulmonary disease, asthma, cancer and / or cirrhosis.
- •Diseases of the aorta, peripheral vascular disease, coronary artery disease (including angina, history of prior myocardial infarction or angina, or history of cardiac catheterization and angioplasty).
- •Use of corticosteroids, amiodarone or dopamine, as well as any drug that interferes with the levels of thyroid hormones and / or thyroid function.
- •Use of drugs that interfere with autonomic adaptation mechanism, such as beta-blockers, prolopa and calcium channel blockers. Hypertensive patients without use of such drugs may be included.
- •Patients bedridden, wheelchair or with physical limitations (joint and muscle) to prevent the standing position for at least 20 minutes and the realization of the cardiopulmonary exercise test.
- •Obesity with a body mass index equal or greater than 35 kg/m2.
研究组 & 干预措施
Methimazole,
Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).
After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.
Variables considered in this study:
- TSH and FT4
- Questionnaire of Quality of life for older adults (WHOQOL-OLD)
- Mini-Mental State Examination
- Geriatric Depression Scale
- Cardiopulmonary exercise testing - cardiopulmonary capacity
干预措施: Methimazole (Drug)
结局指标
主要结局
Correlate in a population of more than 65 years old, the different levels of serum TSH, with cardiopulmonary capacity and these effects from baseline after treatment with antithyroid drugs
时间窗: six months
Describe the cardiopulmonary capacity in elderly health population of 65 years old or more, in different quartiles of normal range for serum TSH. * Assess the outcome in the cardiopulmonary capacity in seniors aged 65 years old or more, in different quartiles of normal range for serum TSH. * Quantify the possible changes from baseline related to the use of antithyroid drugs in cardiopulmonary capacity in patients aged 65 or more, with the initial serum TSH at the lower limit of the normal range (1.0 mIU/ml)to values of TSH more than 2.0mUI/ml for six months.
次要结局
- Assess the quality of life in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole(six months)
- Assess the mini mental health status in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole(six months)
- Assess the depression scale in seniors aged 65 years old or older, in different quartiles of normal range for serum TSH and these changes from baseline after use of methimazole(six months)
研究者
Dhianah Santini de Oliveira Chachamovitz
Principal Investigator
Universidade Federal do Rio de Janeiro