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Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Fernanda Rossi Paolillo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01745042
First received: December 3, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Postmenopausal Disorder
 Other: Clinical exams

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of Fat Distribution on Metabolic, Cardiovascular and Symptomatic Aspects in Postmenopausal Women

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Relationships between postmenopause and fat distribution [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Anthropometric measurements: waist-to-hip ratio and body mass index


Secondary Outcome Measures:
  • Comparison of aerobic capacity between android and gynoid postmenopausal women [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Progressive aerobic testing on treadmill (Modified Bruce Protocol): estimated maximum oxygen consumption; metabolic equivalents; blood pressure; heart rate

  • Comparison of metabolic parameters between android and gynoid postmenopausal women [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Biochemical tests: the serum level of estradiol, urea, creatinine, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, insulin and glucose

  • Comparison of quality of life between android and gynoid postmenopausal women [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Menopause Rating Scale (MRS): somatic symptoms; psychological symptoms; urogenital-sexual problems

  • Comparison of the body composition between android and gynoid postmenopausal women [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Body composition: bipolar electrical bioimpedance (body fat and lean mass) and skinfolds (triceps, subscapular, suprailiac, abdominal, anterior thigh, medial calf)


Enrollment: 45
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
android postmenopausal women
Clinical exams
 Other: Clinical exams
Physiological and biochemical tests; quality of life questionnaire; body composition measurement
gynoid postmenopausal women
Clinical exams
 Other: Clinical exams
Physiological and biochemical tests; quality of life questionnaire; body composition measurement

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

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women from a community sample of São Carlos city - São Paulo State - Brazil.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745042

Locations
Brazil
Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
São Carlos, São Paulo, Brazil, 676
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: Audrey Borghi-Silva, Ph.D Department of Physical Therapy, Federal University of São Carlos (UFSCar)
Study Director: Cristina Kurachi, Ph.D Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Study Director: Vanderlei S Bagnato, Ph.D Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Principal Investigator: Fernanda R. Paolillo, Ph.D Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
  More Information

Publications:

Responsible Party: Fernanda Rossi Paolillo, Federal University of São Carlos, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01745042     History of Changes
Other Study ID Numbers: 150949/2011-1
Study First Received: December 3, 2012
Last Updated: December 5, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Postmenopausal Women
Body Composition
Metabolic Syndrome
Menopause Symptoms

ClinicalTrials.gov processed this record on May 23, 2013