Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01745042
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)
45
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3
15.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical exams

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.

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Impact of Fat Distribution on Metabolic, Cardiovascular and Symptomatic Aspects in Postmenopausal Women
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Relationships between postmenopause and fat distribution [Baseline]

    Anthropometric measurements: waist-to-hip ratio and body mass index

Secondary Outcome Measures

  1. Comparison of aerobic capacity between android and gynoid postmenopausal women [Baseline]

    Progressive aerobic testing on treadmill (Modified Bruce Protocol): estimated maximum oxygen consumption; metabolic equivalents; blood pressure; heart rate

  2. Comparison of metabolic parameters between android and gynoid postmenopausal women [Baseline]

    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

  3. Comparison of quality of life between android and gynoid postmenopausal women [Baseline]

    Menopause Rating Scale (MRS): somatic symptoms; psychological symptoms; urogenital-sexual problems

  4. Comparison of the body composition between android and gynoid postmenopausal women [Baseline]

    Body composition: bipolar electrical bioimpedance (body fat and lean mass) and skinfolds (triceps, subscapular, suprailiac, abdominal, anterior thigh, medial calf)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fernanda Rossi Paolillo, Federal University of São Carlos, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01745042
Other Study ID Numbers:
  • 150949/2011-1
First Posted:
Dec 7, 2012
Last Update Posted:
Dec 7, 2012
Last Verified:
Dec 1, 2012
Keywords provided by Fernanda Rossi Paolillo, Federal University of São Carlos, University of Sao Paulo

Study Results

No Results Posted as of Dec 7, 2012