Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01142817
First Posted: June 11, 2010
Last Update Posted: August 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital
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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| Study Type: |
Observational
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| Study Design: |
Observational Model: Cohort
Time Perspective: Prospective |
| Official Title: |
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV |
Primary Outcome Measures:
Secondary Outcome Measures:
- Body Composition [ Time Frame: baseline to 12 months ]
Total body fat and abdominal fat measurement, and total lean mass measurement
- Lipid Levels [ Time Frame: baseline to 12 months ]
Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
- Glucose Metabolism [ Time Frame: baseline to 12 months ]
Includes fasting glucose and insulin levels
- Depression [ Time Frame: baseline to 12 months ]
Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
- Quality of Life [ Time Frame: baseline to 12 months ]
Assessed by the Utian Quality of Life Scale
- Vasomotor Symptoms [ Time Frame: Baseline to 12 months ]
Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function
- Systemic Inflammation (as it relates to cardiovascular risk/body composition changes) [ 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.
Whole blood, serum
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| Enrollment: |
66 |
| Study Start Date: |
June 2010 |
| Study Completion Date: |
May 2013 |
| Primary Completion Date: |
May 2013 (Final data collection date for primary outcome measure) |
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HIV Postive Women
Women living with HIV who meet study eligibility criteria
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Healthy Control Subjects
Women without HIV who meet study eligibility criteria
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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.
