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Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01142817
First received: June 10, 2010
Last updated: August 6, 2013
Last verified: August 2013
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Purpose
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.
| Condition |
|---|
| HIV Infections Menopause |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Metabolic and Psychological Changes Associated With Menopause Among Women With HIV |
Resource links provided by NLM:
Further study details as provided by Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital:
Primary Outcome Measures:
- Bone Mineral Density [ Time Frame: baseline to 12 months ]Measurement of bone density at the toal body, lumbar spine and total hip
Secondary Outcome Measures:
- Body Composition [ Time Frame: baseline to 12 months ]Total body fat and abdominal fat measurement, and total lean mass measurement
- Lipid Levels [ Time Frame: baseline to 12 months ]Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
- Glucose Metabolism [ Time Frame: baseline to 12 months ]Includes fasting glucose and insulin levels
- Depression [ Time Frame: baseline to 12 months ]Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
- Quality of Life [ Time Frame: baseline to 12 months ]Assessed by the Utian Quality of Life Scale
- Vasomotor Symptoms [ Time Frame: Baseline to 12 months ]Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function
- 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.
Biospecimen Retention: Samples Without DNA
Whole blood, serum
| Enrollment: | 66 |
| Study Start Date: | June 2010 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
HIV Postive Women
Women living with HIV who meet study eligibility criteria
|
|
Healthy Control Subjects
Women without HIV who meet study eligibility criteria
|
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| Ages Eligible for Study: | 45 Years to 52 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
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).
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01142817
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142817
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Sara E Looby, PhD, ANP | Massachusetts General Hospital |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sara E. Dolan Looby, PhD, ANP-BC, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01142817 History of Changes |
| Other Study ID Numbers: |
2009P-001315 |
| Study First Received: | June 10, 2010 |
| Last Updated: | August 6, 2013 |
Keywords provided by Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital:
|
HIV Women Menopause Dyslipidemia Bone Mineral Density |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on July 21, 2017