Type 2 Diabetes, Cardiovascular Comorbidity and Environmental Temperature: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of systolic and diastolic blood pressure
研究概览
简要总结
Both high and low environmental temperatures are associated worldwide with higher morbidity and mortality and an estimated 8% of the mortality is estimated to relate to non-optimum temperatures. The majority of the adverse health effects occur at to low, and not high temperatures, and already with a modest change in temperature. Persons with type 2 diabetes can be sensitive to the effect of temperature due to their altered neural, metabolic and circulatory functions. The pathophysiological responses of type 2 diabetes in a cold and hot environment are not known.
The aim of the study is to examine how advanced type 2 diabetes (disease progression >10 years) alone, an in conjunction with coronary artery diseases and hypertension affect neural, cardiovascular and metabolic responses in a cold and hot environment.
Type 2 diabetes is associated with altered neural regulation, weakened cardiovascular function, structural changes in blood vessels, altered blood constitution and metabolic disturbances. These affect thermoregulation and result in increased susceptibility to cold (lesser heat production, increased heat loss) and heat (lesser sweating and heat loss).
The patients are exposed under controlled conditions in a random order to both cold (+10°C) and heat (+44°C) while resting and lightly clothed for 90 min at a time. The exposure itself is preceded by baseline measurements of the parameters of interest, and followed by repeating the same measurements after the exposure.
The topic of the research is very relevant due to the worldwide epidemic of type 2 diabetes. Simultaneously, the comorbid conditions associated with diabetes become more common and are related to a higher occurrence of cardiac events. The research information is useful for all individuals with type 2 diabetes in their protection and self-management of the disease, and enabling to maintain functional ability in a cold or hot environment. The research knowledge can be utilized when developing weather warning systems for the identification of susceptible populations. Health care personnel may utilize the research information while advising their patients and for proper care. An increased awareness of the health effects of both low and high temperatures improve the functional ability of individuals and reduced help reducing morbidity and mortality from weather conditions.
详细描述
Significance of the project in relation to current knowledge Temperature, health and climate change. Both high and low and environmental temperatures cause discomfort and degradation of physical performance. These normal physiological responses elicited to lose or preserve body heat can aggravate the course of chronic diseases and lead to a higher amount of health care visits, hospitalizations, or deaths. Globally, most of the adverse health effects are caused by cold, rather than heat, and occur already at mild non-optimal temperatures.
Environmental temperatures reflect the primary effects of climate change (CC), the biggest health threat of the 21st century. CC primarily involves a global increase of temperatures, and especially in the frequency, intensity and duration of heat extremes. Connected to the variability of weather, also higher amounts of precipitation, clouds, and winds are predicted. Northern climates, such as Finland, are subjects to huge annual variations in temperature (from ca. +30°C to -30°C) together with periodic prolongation of temperature extremes (heat and cold spells). Global projections predict that health effects of cold continue to outnumber those of heat in Finland, but heat exposure becomes increasingly important, also due to the lack of adaptation to high temperatures of northern residents.
T2D and temperature. The global occurrence of diabetes is 425 million people of which 77% are working aged and is estimated to increase to 629 million people by 2045. Type 2 diabetes (T2D) accounts for 90% of the diabetic patients. In Finland, the incidence of T2D has increased markedly in men for the last 35 years. Diabetes of all types can lead to micro- (retino-, nephro- and neuropathies) and macrovascular (cerebral, coronary and peripheral arterial disease) complications and resulting in higher morbidity and premature deaths. The economic burden of the direct and indirect costs of diabetes is tremendous and represented 1.8% of the GDP in 2015.
Epidemiological studies suggest that non-optimal environmental temperatures and diabetes are associated with higher morbidity and mortality. A study of 4.5 Million GP consultations showed that persons having T2D sought medical attention more often with both low and high temperatures. Furthermore, cold and hot temperatures were associated with a 12% and a 30% increase in diabetes-related hospitalizations.
Heat exposure may involve a lesser ability to lose additional body heat (higher heat load) to the environment and higher cardiovascular strain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking
- •Type 2 diabetes
- •Hypertension
排除标准
- •Chronic respiratory diseases
- •Coronary artery diseases
结局指标
主要结局
Change of systolic and diastolic blood pressure
时间窗: 10, 20 and 30 minutes before the intervention, during the intervention in 10 minutes intervals, and 5, 10, 15, 20 25 and 30 minutes after the intervention.
Brachial, central and beat-to-beat systolic and diastolic blood pressure
次要结局
- Skin and body temperature(3 hours)
- Sweating(During the 60 minutes intervention period and immediately after the intervention.)
- Electrocardiogram, ECG(3 hours)
- Metabolic rate(During the 60 minutes intervention period.)