Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

NCT ID: NCT01142817

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

HIV Infections; Menopause

Keywords

HIV; Women; Menopause; Dyslipidemia; Bone Mineral Density

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV Postive Women

Women living with HIV who meet study eligibility criteria

No interventions assigned to this group

Healthy Control Subjects

Women without HIV who meet study eligibility criteria

No interventions assigned to this group

Eligibility Criteria

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).

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• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sara E. Dolan Looby, PhD, ANP-BC

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara E Looby, PhD, ANP

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21924646 (View on PubMed)

Looby SE, Shifren J, Corless I, Rope A, Pedersen MC, Joffe H, Grinspoon S. Increased hot flash severity and related interference in perimenopausal human immunodeficiency virus-infected women. Menopause. 2014 Apr;21(4):403-9. doi: 10.1097/GME.0b013e31829d4c4c.

Reference Type: DERIVED

PMID: 23820600 (View on PubMed)

Other Identifiers

2009P-001315

Identifier Type: -

Identifier Source: org_study_id