Obesity
Conditions
Interventions
Prospective cohort study approved by the Research Ethics Committee of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (HCFMUSP). After initial screening, volunteers
Z79.890
V03.175.500
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
35 Years to 55 Years
Inclusion criteria
Inclusion criteria: Hormonal therapy (HT) group: age between 45 and 55 years; absence of menstruation in the last six months and no more than 36 months; last spontaneous menstruation occurring after 40 years of age; plasma FSH levels greater than 40 IU/L and estradiol levels less than 25 pg/mL; clinical indication for HT; intention to administer HT for 16 or more uninterrupted weeks; have education greater than or equal to 7 years of formal study. N-HT group: women ineligible and/or who refused to receive hormone therapy: age between 45 and 55 years; absence of menstruation in the last six months and no more than 36 months; last spontaneous menstruation occurring after 40 years of age; plasma FSH levels greater than 40 IU/L and estradiol levels less than 25 pg/mL; have education greater than or equal to 7 years of formal study. Reference Group of pre-menopausal women: age between 35 and 40 years; have regular menstrual cycles; have education greater than or equal to 7 years of formal study
Exclusion criteria
Exclusion criteria: HT group: previous use of HT; use of antidepressants, anticonvulsants, benzodiazepines or other drugs with effects on the central nervous system; patients with major depressive disorder, anxiety disorder, bipolar affective disorder, schizophrenia or any other psychiatric disorder and neurological diseases with an impact on cognition; personal history of breast cancer; history of venous thromboembolism; history of stroke; established coronary disease; active liver disease; high-risk endometrial cancer; uterine bleeding of unknown cause. N-HT group: having undergone or currently undergoing non-hormonal pharmacological therapies for menopause; use of antidepressants, anticonvulsants, benzodiazepines or other drugs with effects on the central nervous system; women with major depressive disorder, anxiety disorder, bipolar affective disorder, schizophrenia or any other psychiatric disorder and neurological diseases with an impact on cognition; personal history of breast cancer; history of venous thromboembolism; history of stroke; established coronary disease; active liver disease; high-risk endometrial cancer; uterine bleeding of unknown cause. Reference Group of premenopausal women: irregular menstrual cycles; absence of menstruation in the last six months; having used or using contraceptive methods; use of antidepressants, anticonvulsants, benzodiazepines or other drugs with an effect on the central nervous system; women with major depressive disorder, anxiety disorder, bipolar affective disorder, schizophrenia or any other psychiatric disorder and neurological diseases with an impact on cognition; personal history of breast cancer; history of venous thromboembolism; history of stroke; established coronary disease; active liver disease; high-risk endometrial cancer; uterine bleeding of unknown cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate for 6 months the effects of hypoestrogenism and hormonal therapy on brain function linked to appetite control in postmenopausal women, determined by means of functional magnetic resonance imaging exams at the beginning and end of the study.;To evaluate for 6 months the effects of hypoestrogenism and hormonal therapy on brain function linked to cognitive control in postmenopausal women, determined by means of functional magnetic resonance imaging exams at the beginning and end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify possible factors (e.g., sociodemographic characteristics, BMI, physical capacity, quality of life questionnaires, level of physical activity, quality of sleep, sexual and mental health function, biochemical and body composition tests) associated with cerebral and neuropsychological outcomes resulting from hypoestrogenism and hormone therapy in postmenopausal women. | — |
Countries
Brazil
Contacts
Public ContactCintia Cercato
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed