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临床试验/NCT07100639
NCT07100639尚未招募不适用

From Exposome to Health Outcomes: A Population-Based Approach to Understanding and Mitigating Early Menopause in Singapore's Diverse Communities

Institute for Human Development and Potential (IHDP), Singapore0 个研究点目标入组 400 人开始时间: 2025年8月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Early menopause

研究概览

简要总结

Brief Summary

The goal of this observational study is to learn how environmental factors, lifestyle choices, and social conditions affect the timing of menopause in Asian women aged 40-50 years living in Singapore. The main aims of the project are the following:

  • Do environmental pollutants and lifestyle exposures contribute to earlier menopause in Asian women?
  • What biological changes occur when women are exposed to harmful environmental factors during menopause transition?

Participants will be followed for 18 months and will complete questionnaires about their health history, lifestyle, diet, and environmental exposures. Participants will provide blood, urine, stool, hair, and nail samples for laboratory analysis and undergo basic health assessments including weight, blood pressure, and bone density measurements. Participants will wear activity monitors and air pollution sensors for 7 days and attend follow-up visits at 6 months, 12 months, and 18 months to track changes in their health. This data will be obtained during the baseline visit.

详细描述

Detailed Description

Background and Rationale: Early menopause, defined as cessation of ovarian function before age 45, affects approximately 5-12% of women globally and is associated with increased risks of cardiovascular disease, osteoporosis, and cognitive decline. Growing evidence suggests that environmental exposures, including persistent organic pollutants, air pollution, and endocrine-disrupting chemicals, may accelerate ovarian aging and contribute to earlier menopausal timing. The exposome concept involves the totality of environmental exposures experienced by individuals throughout their lifetimes, including chemical, physical, biological, and social factors.

Study Hypothesis We hypothesize that combined exposure to environmental pollutants, lifestyle factors, and social conditions accelerates biological aging processes and leads to earlier menopause onset in women. These exposome effects are mediated through changes in gene expression patterns, metabolic profiles, and gut microbiome composition, ultimately increasing the risk of adverse health outcomes.

Study Design: This is a prospective observational cohort study employing a longitudinal design with 18-month follow-up. The study integrates comprehensive exposome assessment with multi-omics profiling to investigate the complex relationships between environmental factors and menopausal health outcomes in a multi-ethnic Asian population.

Population and Setting: Four hundred women aged 40-50 years will be recruited from diverse communities across Singapore. Participants must have experienced no menstruation for the last 2 months or irregular menstrual cycles in the last 6 months, be proficient in English, and plan to reside in Singapore for the study duration. The study will include Chinese, Malay, and Indian ethnicities reflecting Singapore's demographic composition.

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
40 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female participants aged 40-50 years No menstruation for the last 2 months or irregular menstrual cycles in the last 6 months Chinese, Malay, or Indian ethnicity Proficient in English language Planning to reside in Singapore for next 2 years Willing to provide informed consent and comply with study procedures

排除标准

  • In menopause (12 consecutive months without menstruation) Currently pregnant or planning to conceive History of bilateral oophorectomy and/or hysterectomy Currently receiving hormone therapy, including estradiol replacement therapy or oral contraceptives Diagnosed with premature ovarian insufficiency before 40 years of age Diagnosis of autoimmune conditions and/or chromosomal abnormalities known to affect ovarian function Diagnosis of severe cognitive impairment and/or mental disorders Received cancer treatment in the past 12 months

结局指标

主要结局

Early menopause

时间窗: 18 months

Time to menopause onset

时间窗: 18 months

• Menopausal symptom severity score using standardized assessment tools

次要结局

未报告次要终点

研究者

发起方
Institute for Human Development and Potential (IHDP), Singapore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kothandaraman Narasimhan, Ph.D.

Principal Investigator

Institute for Human Development and Potential (IHDP), Singapore

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