Trial record 13 of 42 for:
" May 12, 2010":" June 11, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
This study has been completed.
First Posted: June 11, 2010
Last Update Posted: August 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
Primary Outcome Measures:
Biospecimen Retention: Samples Without DNA
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.
Whole blood, serum
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
HIV Postive Women
Women living with HIV who meet study eligibility criteria
Healthy Control Subjects
Women without HIV who meet study eligibility criteria
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.
Information from the National Library of Medicine
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|Ages Eligible for Study:
||45 Years to 52 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142817
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
||Sara E Looby, PhD, ANP
||Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Sara E. Dolan Looby, PhD, ANP-BC, Principal Investigator, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
||June 10, 2010
||June 11, 2010
|Last Update Posted:
||August 7, 2013
Keywords provided by Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital:
Bone Mineral Density
Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases