Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

This study has been completed.
Sponsor:
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

June 10, 2010
August 6, 2013
June 2010
May 2013   (final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Measurement of bone density at the toal body, lumbar spine and total hip
Same as current
Complete list of historical versions of study NCT01142817 on ClinicalTrials.gov Archive Site
  • Body Composition [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Total body fat and abdominal fat measurement, and total lean mass measurement
  • Lipid Levels [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
  • Glucose Metabolism [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Includes fasting glucose and insulin levels
  • Depression [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
  • Quality of Life [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Assessed by the Utian Quality of Life Scale
  • Vasomotor Symptoms [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment of inflammatory biomarkers and cytokines including CRP,IL-6, TNF-α, and PAI-1, as well as adiponectin.
  • Body Composition [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Total body fat and abdominal fat measurement, and total lean mass measurement
  • Lipid Levels [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Lipid levels include total cholesterol, low density lipoprotein, high density lipoprotein, and triglyceride levels
  • Glucose Metabolism [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Includes fasting glucose and insulin levels
  • Depression [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Depressive symptoms assessed by the Centers for Epidemiologic Studies Depression Scale (CES-D)
  • Quality of Life [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    Assessed by the Utian Quality of Life Scale
  • Vasomotor Symptoms [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    Assessed by the Menopause Rating Scale, includes hot flashes, mood, sleep, genitourinary symptoms, and sexual function
Not Provided
Not Provided
 
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV
Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood, serum

Non-Probability Sample

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.

  • HIV Infections
  • Menopause
Not Provided
  • HIV Postive Women
    Women living with HIV who meet study eligibility criteria
  • Healthy Control Subjects
    Women without HIV who meet study eligibility criteria
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2013
May 2013   (final data collection date for primary outcome measure)

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).

    -

Female
45 Years to 52 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01142817
2009P-001315
No
Sara E. Dolan Looby, PhD, ANP-BC, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Sara E Looby, PhD, ANP Massachusetts General Hospital
Massachusetts General Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP