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Metabolic and Psychological Changes Associated With Menopause Among Women With HIV

This study is ongoing, but not recruiting participants.
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: February 11, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Whole blood, serum


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 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
Genders 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:

  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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  Contacts and Locations
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:

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: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
HIV
Women
Menopause
Dyslipidemia
Bone Mineral Density

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2013