Clinical trial NCT01142817: Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
Official title: Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Menopause
Keywords: HIV
Women
Menopause
Dyslipidemia
Bone Mineral Density
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 66
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects in the perimenopausal transition will be recruited via referral by infectious disease providers, newspaper advertisement, posted flyers, community based programs at local AIDS Service Organizations and Partners subject recruitment broadcast at Massachusetts General Hospital (MGH). The HIV negative control subjects will be recruited through advertisements, flyers, and email announcements. Both HIV positive and negative subjects will be recruited from the same neighborhoods to ensure similar demographic characteristics.

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.

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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Primary outcomes:
measure: Bone Mineral Density
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Body Composition
timeFrame: baseline to 12 months
measure: Lipid Levels
timeFrame: baseline to 12 months
measure: Glucose Metabolism
timeFrame: baseline to 12 months
measure: Depression
timeFrame: baseline to 12 months
measure: Quality of Life
timeFrame: baseline to 12 months
measure: Vasomotor Symptoms
timeFrame: Baseline to 12 months
measure: Systemic Inflammation (as it relates to cardiovascular risk/body composition changes)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sara E Looby, PhD, ANP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.