Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

Conditions
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HIV Infections, Menopause

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females age 45 -52. 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. 3. Women with HIV must have previously documented HIV and be receiving a stable treatment regimen for > 3 months. Exclusion Criteria: 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). -

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV Postive Women<br>Women living with HIV who meet study eligibility criteria | |
| Healthy Control Subjects<br>Women without HIV who meet study eligibility criteria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | Measurement of bone density at the toal body, lumbar spine and total hip | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | Total body fat and abdominal fat measurement, and total lean mass measurement | baseline to 12 months | 
| Lipid Levels | Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels | baseline to 12 months | 
| Glucose Metabolism | Includes fasting glucose and insulin levels | baseline to 12 months | 
| Depression | Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D) | baseline to 12 months | 
| Quality of Life | Assessed by the Utian Quality of Life Scale | baseline to 12 months | 
| Vasomotor Symptoms | Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function | Baseline to 12 months | 
| Systemic Inflammation (as it relates to cardiovascular risk/body composition changes) | Assessment of inflammatory biomarkers and cytokines including CRP,IL-6, TNF-α, and PAI-1, as well as adiponectin. | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Women, Menopause, Dyslipidemia, Bone Mineral Density