Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
This study will investigate the prevalence and extent of both metabolic and psychosocial changes associated with the menopause transition over 1 year among women with HIV compared to women without HIV of similar age, weight, menstrual status, and ethnic background. It is hypothesized that HIV positive women will demonstrate increased abdominal fat, abnormal cholesterol and blood sugar levels, reduced bone density, and greater psychosocial challenges than HIV negative women during the menopause transition.
详细描述
Treatment with combination antiretroviral therapy (ART) has resulted in substantial improvement in survival among women living with HIV in the United States, many of whom have entered or will soon enter the menopause transition. Significant changes are seen across the menopause transition among women without HIV including increased abdominal fat and waist circumference, reduced muscle mass, and changes in lipids, glucose metabolism and bone density. HIV and potentially ART use have been associated with similar manifestations such as reduced bone density, changes in lipid and glucose metabolism, and body composition, though little is known regarding how the virus may influence or exacerbate such changes across the menopause transition. In addition to metabolic factors, menopause has been associated with changes in mood state, decreased quality of life, and presence of vasomotor symptoms among women without HIV. Psychosocial indices, such as depression and decreased quality of life are common among women with HIV, and may manifest or worsen during the menopause transition. However, research investigating the presence and acuity of these symptoms among women with HIV during menopause is limited.
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
- 45 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females age 45 -
- •Females in the perimenopausal transition characterized by the presence of abnormal menstrual function, defined as less than 3 periods in the past 3 months, 1 cycle >60 days in length in the prior 6 months, or irregular menses in 2 or more cycles within the past 6 months. Women who have been amenorrheic for >12 months will not be eligible.
- •Women with HIV must have previously documented HIV and be receiving a stable treatment regimen for > 3 months.
排除标准
- •Use of estrogen, combination hormone replacement therapy, oral contraceptive pills/patches, Depo Provera, glucocorticoids, testosterone, growth hormone or other anabolic steroids within the past 6 months.
- •Diabetes and current use of insulin, or medications known to affect glucose or insulin levels.
- •Positive pregnancy test or recently pregnant within the past year or lactating.
- •Presence of active cancers.
- •Current use of bisphosphonates, or a diagnosis of Paget's disease or other illnesses known to affect bone (Use of calcium and Vitamin D will be permitted).
- •Opportunistic infection within 3 months of study participation (HIV positive subjects).
结局指标
主要结局
Bone Mineral Density
时间窗: baseline to 12 months
Measurement of bone density at the toal body, lumbar spine and total hip
次要结局
- Quality of Life(baseline to 12 months)
- Body Composition(baseline to 12 months)
- Lipid Levels(baseline to 12 months)
- Glucose Metabolism(baseline to 12 months)
- Vasomotor Symptoms(Baseline to 12 months)
- Depression(baseline to 12 months)
- Systemic Inflammation (as it relates to cardiovascular risk/body composition changes)(Baseline to 12 months)
研究者
Sara E. Dolan Looby, PhD, ANP-BC
Principal Investigator
Massachusetts General Hospital