NCT04943354已完成不适用
Associations of Combinations of Single-nucleotide Polymorphisms and Behavioural Risk Factors With Non-communicable Diseases and Adverse Outcomes in Women With Premature Ovarian Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Age (years)
研究概览
简要总结
Research objective.
- To study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with non-communicable diseases and adverse outcomes in women with premature ovarian failure.
Research objectives:
- To study the associations between combinations of single-nucleotide polymorphisms and behavioural risk factors with heart rate disorders and adverse outcomes in women with premature ovarian failure
- Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with stable STIs in women with premature ovarian failure.
- Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with thrombomolia in women with premature ovarian failure
- Study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors and adverse cardiovascular outcomes in women with premature ovarian failure.
详细描述
Methods of research:
- Questionnaire .
- Clinical examination
- Blood levels of sex hormones
- Blood lipid spectrum
- Coagulogram
- Glycemic profile
- EchoCG
- SMAD
- ECG
- Daily ECG monitoring
- Questionnaire EQ-5D
- Single-nucleotide polymorphisms of genes of the reninangyotensin-aldosterone system group (AGT, ACE), endothelial dysfunction (NOS3, EDN1), thrombosis-associated (ITGB3, ITGA2, FGB, GPIBA, SERPINE PAI1), pro-inflammatory (CRP, IL17A, IL2, IL10 1, IL10 2, TNFα, CRP 4, IL6, TLR2, TLR3, TLR4, TLR6, TLR9) polymorphisms.
Subject of study.
Women under 45 with Premature Ovarian Failure (PED). It is planned to include 615 people in the study. The study will have both prospective and retrospective parts. Patients will be divided into 4 groups:
- Women with OED without cardiovascular disease
- Women with OAI who have cardiovascular disease
- Control group No 1 Women with normal ovarian function without cardiovascular disease.
- Control group 2 Women with normal ovarian function without cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women under 45 years old
- •presence of premature ovarian insufficiency in the medical history
排除标准
- •male gender
- •age over 45 years
结局指标
主要结局
Age (years)
时间窗: 2 year
Patient age in years
次要结局
- Menarche (years)(2 year)
研究者
研究点 (2)
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