Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT01142817
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.
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Notify Me45 year–52 year
Female
Observational
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Time frame: baseline to 12 months
Measurement of bone density at the toal body, lumbar spine and total hip
Time frame: baseline to 12 months
Total body fat and abdominal fat measurement, and total lean mass measurement
Time frame: baseline to 12 months
Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
Time frame: baseline to 12 months
Includes fasting glucose and insulin levels
Time frame: baseline to 12 months
Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline to 12 months
Assessed by the Utian Quality of Life Scale
Time frame: Baseline to 12 months
Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function
Time frame: Baseline to 12 months
Assessment of inflammatory biomarkers and cytokines including CRP,IL-6, TNF-α, and PAI-1, as well as adiponectin.
Massachusetts General Hospital
Other
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