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Completed

NCT Number: NCT01142817

Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

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Treatment and study plan

Primary outcomes

  1. Bone Mineral Density

    Time frame: baseline to 12 months

    Measurement of bone density at the toal body, lumbar spine and total hip

Secondary outcomes

  1. Body Composition

    Time frame: baseline to 12 months

    Total body fat and abdominal fat measurement, and total lean mass measurement

  2. Lipid Levels

    Time frame: baseline to 12 months

    Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels

  3. Glucose Metabolism

    Time frame: baseline to 12 months

    Includes fasting glucose and insulin levels

  4. Depression

    Time frame: baseline to 12 months

    Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)

  5. Quality of Life

    Time frame: baseline to 12 months

    Assessed by the Utian Quality of Life Scale

  6. Vasomotor Symptoms

    Time frame: Baseline to 12 months

    Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function

  7. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2010
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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