Lipid Profile and Diabetes Risk of HIV Patients Treated by Austrian HIV -Physicians: a 7 Year Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Changes in dyslipidemia prevalence from baseline - total cholesterol
研究概览
简要总结
Traditional risk factors for cardiovascular diseases have been shown to have an even higher impact in the HIV infected population. The original study from 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (namely, dyslipidaemia and diabetes mellitus) in people living with HIV (PLWHIV) in Austria. The aim of this follow up study is to see the progression of our study sample and to see what prevalence levels may be found after 7 years. This epidemiological evaluation is conceptualized to document real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk and to compare with the baseline values from the original study.
详细描述
Background: In developed countries, an increase in cardiovascular events and related mortality has been seen; even more prominent in people living with HIV (PLWHIV) as compared to non-HIV control groups. Studies have shown dyslipidaemia and diabetes mellitus type 2 as important risk factors for cardiovascular diseases in PLWHIV.
The original study by this group in 2014 was a cross sectional study into the prevalence of cardiovascular risk factors (dyslipidaemia and diabetes mellitus) in PLWHIV in Austria and identified characteristics associated with these two risk factors. In that previous study dyslipidaemia was diagnosed in 46.3% of cases and half of all the study participants showed an increased insulin resistance. Eight persons (1.6%) fulfilled the criteria for diabetes mellitus type 2.
Purpose: The aim of this follow up study is to see the progression of our study sample and to see what prevalence levels may be found after 7 years. Additionally, a look into previously identified characteristics associated with dyslipidaemia and diabetes mellitus type may provide valuable insight into the temporal effects. Finally, examining resource use this population in terms of medications can provide insights into current practice and its associated costs in Austria, as well as an estimate of the added medication cost of dyslipidaemia and diabetes mellitus type 2 in this population.
It is our aim to close the existing knowledge gap on the role of dyslipidaemia and diabetes mellitus on cardiovascular risk among PLWHIV in Austria. Therefore, the investigation will be carried out by using routine data within minimum additional effort to the study team. The data obtained may serve as a base for future decisions on treatment of the Austrian HIV population.
Study details: Our epidemiologic evaluation documents real life major cardiovascular risk factors of HIV-infected patients, focusing on lipid profiles and diabetes mellitus risk. The gathered data from approximately 450 originally enrolled patients will be compared with the baseline values analysed in the original study in 2014.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only Participants who participated in the previous study
- •Adult (older than 18 years)
- •male and female patients diagnosed and confirmed HIV diagnosis, given written informed consent
排除标准
- •No participation in the original study
结局指标
主要结局
Changes in dyslipidemia prevalence from baseline - total cholesterol
时间窗: 7 years
Total cholesterol values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline - HDL-cholesterol
时间窗: 7 years
HDL-Cholesterol values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline - Non-HDL-Cholesterol
时间窗: 7 years
Non-HDL-Cholesterol will be calculated additionally.
Changes in dyslipidemia prevalence from baseline - Apolipoprotein B
时间窗: 7 years
Apolipoprotein B values will be analyzed by an authorized laboratory
Changes from baseline in diabetes mellitus type II prevalence
时间窗: 7 years
The diabetes mellitus prevalence will be assessed through patient history (checking for a diabetes mellitus type II diagnosis since baseline)
Changes in dyslipidemia prevalence from baseline- triglycerides
时间窗: 7 years
Triglyceride values will be analyzed by an authorized laboratory
Changes in dyslipidemia prevalence from baseline - LDL-cholesterol
时间窗: 7 years
a. LDL will be calculated using the Friedewald formula. As the Friedewald formula does not work in case of triglycerides \> 300, in these patients only non-HDL-C will be used.
次要结局
- Changes from baseline in drug utilization for PLWHIV(7 years)
- Changes from baseline in the lipid profile of patients in correlation to prescribed antiretroviral regime(7 years)
- Incidence of diabetes mellitus type 2 in patients who were diagnosed found to be insulin resistant in the first study in 2014(7 years)
- Description of risk profile for cardiovascular events in the sample population(at follow up recruitment, Day 0)
- Documentation of any major cardiovascular events (stroke or heart attack)(during 7 years)
- Changes from baseline in therapy prescriptions of patients who were found to have hyperlipidaemia during first study in 2014(7 years)
- Prevalence of diabetes mellitus type 2 in correlation to the prescribed antiretroviral regime during the follow up time(7 years)
- Changes from baseline in therapeutic regimes within those patients who were identified as having diabetes mellitus type 2 in the first study in 2014(7 years)
研究者
Moritz Oberndorfer
Researcher
Medical University of Vienna