Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

Completed

• Conditions: Menopause; HIV Infections

• Registration Number: NCT01142817
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1. Females age 45 -52.
2. 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

1. 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.

2. Diabetes and current use of insulin, or medications known to affect glucose or insulin levels.

3. Positive pregnancy test or recently pregnant within the past year or lactating.

4. Presence of active cancers.

5. 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).

6. Opportunistic infection within 3 months of study participation (HIV positive subjects).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	baseline to 12 months	Measurement of bone density at the toal body, lumbar spine and total hip

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States