Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

HIV Infections Clinical Trial

Official title:

Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142817
• Other study ID #: 2009P-001315
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: August 6, 2013
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 52 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections
• Menopause

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Looby SE. Menopause-associated metabolic manifestations and symptomatology in HIV infection: a brief review with research implications. J Assoc Nurses AIDS Care. 2012 May-Jun;23(3):195-203. doi: 10.1016/j.jana.2011.06.008. Epub 2011 Sep 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	Measurement of bone density at the toal body, lumbar spine and total hip	baseline to 12 months	No
Secondary	Body Composition	Total body fat and abdominal fat measurement, and total lean mass measurement	baseline to 12 months	No
Secondary	Lipid Levels	Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels	baseline to 12 months	No
Secondary	Glucose Metabolism	Includes fasting glucose and insulin levels	baseline to 12 months	No
Secondary	Depression	Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)	baseline to 12 months	No
Secondary	Quality of Life	Assessed by the Utian Quality of Life Scale	baseline to 12 months	No
Secondary	Vasomotor Symptoms	Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function	Baseline to 12 months	No
Secondary	Systemic Inflammation (as it relates to cardiovascular risk/body composition changes)	Assessment of inflammatory biomarkers and cytokines including CRP,IL-6, TNF-a, and PAI-1, as well as adiponectin.	Baseline to 12 months	No