Clinical trial NCT01745042: Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women
Official title: Impact of Fat Distribution on Metabolic, Cardiovascular and Symptomatic Aspects in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Disorder
Keywords: Postmenopausal Women
Body Composition
Metabolic Syndrome
Menopause Symptoms
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2012-12-07
Enrollment: 45
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women from a community sample of São Carlos city - São Paulo State - Brazil.

Brief summary: The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and symptomatic profiles in postmenopausal women.

Detailed description: When aging, the body composition changes, leading to a reduction of muscle mass and strength, and to an increase in total body fat. These body composition changes have especially been observed in postmenopausal women, due to the hormonal changes taking place. After the menopause, the gynoid fat distribution with fat deposits in the gluteo-femoral region changes to an android fat distribution with an increased upper body fat, especially in the abdominal region. These consequences of the menopause associated with a decrease in aerobic capacity and reduced total energy expenditure may lead to the metabolic syndrome (MetS). The aim of this study was to investigate the anthropometric, metabolic, cardiovascular and symptomatic profile in gynoid and android postmenopausal women.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Caucasian
* 50-60 years of age

Exclusion Criteria:

* Neurological disease
* Pulmonary disease
* Cardiac disease
* Oncological disease
* Musculotendinous or articular injuries
* Hormone replacement therapy
* Cigarette smoking

Primary outcomes:
measure: Relationships between postmenopause and fat distribution
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of aerobic capacity between android and gynoid postmenopausal women
timeFrame: Baseline
measure: Comparison of metabolic parameters between android and gynoid postmenopausal women
timeFrame: Baseline
measure: Comparison of quality of life between android and gynoid postmenopausal women
timeFrame: Baseline
measure: Comparison of the body composition between android and gynoid postmenopausal women
timeFrame: Baseline
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
state: São Paulo
Study officials:
affiliation: Department of Physical Therapy, Federal University of São Carlos (UFSCar)
name: Audrey Borghi-Silva, Ph.D
role: STUDY_DIRECTOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Cristina Kurachi, Ph.D
role: STUDY_DIRECTOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Vanderlei S Bagnato, Ph.D
role: STUDY_DIRECTOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Fernanda R. Paolillo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolillo FR, Milan JC, Bueno Pde G, Paolillo AR, Borghi-Silva A, Parizotto NA, Arena R, Kurachi C, Bagnato VS. Effects of excess body mass on strength and fatigability of quadriceps in postmenopausal women. Menopause. 2012 May;19(5):556-61. doi: 10.1097/gme.0b013e3182364e80.
citation: Paolillo FR, Milan JC, Aniceto IV, Barreto SG, Rebelatto JR, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Effects of infrared-LED illumination applied during high-intensity treadmill training in postmenopausal women. Photomed Laser Surg. 2011 Sep;29(9):639-45. doi: 10.1089/pho.2010.2961. Epub 2011 Jul 12.
citation: Paolillo FR, Corazza AV, Borghi-Silva A, Parizotto NA, Kurachi C, Bagnato VS. Infrared LED irradiation applied during high-intensity treadmill training improves maximal exercise tolerance in postmenopausal women: a 6-month longitudinal study. Lasers Med Sci. 2013 Feb;28(2):415-22. doi: 10.1007/s10103-012-1062-y. Epub 2012 Mar 2.
citation: Blumel JE, Legorreta D, Chedraui P, Ayala F, Bencosme A, Danckers L, Lange D, Espinoza MT, Gomez G, Grandia E, Izaguirre H, Manriquez V, Martino M, Navarro D, Ojeda E, Onatra W, Pozzo E, Prada M, Royer M, Saavedra JM, Sayegh F, Tserotas K, Vallejo MS, Zuniga C; Collaborative Group for Research of the Climacteric in Latin America (REDLINC). Optimal waist circumference cutoff value for defining the metabolic syndrome in postmenopausal Latin American women. Menopause. 2012 Apr;19(4):433-7. doi: 10.1097/gme.0b013e318231fc79.
citation: Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.