Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women

December 5, 2012 updated by: Fernanda Rossi Paolillo, University of Sao Paulo

Impact of Fat Distribution on Metabolic, Cardiovascular and Symptomatic Aspects in Postmenopausal Women

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • São Paulo
      • São Carlos, São Paulo, Brazil, 676
        • Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
android postmenopausal women
Clinical exams
Physiological and biochemical tests; quality of life questionnaire; body composition measurement
gynoid postmenopausal women
Clinical exams
Physiological and biochemical tests; quality of life questionnaire; body composition measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationships between postmenopause and fat distribution
Time Frame: Baseline
Anthropometric measurements: waist-to-hip ratio and body mass index
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of aerobic capacity between android and gynoid postmenopausal women
Time Frame: Baseline
Progressive aerobic testing on treadmill (Modified Bruce Protocol): estimated maximum oxygen consumption; metabolic equivalents; blood pressure; heart rate
Baseline
Comparison of metabolic parameters between android and gynoid postmenopausal women
Time Frame: 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
Baseline
Comparison of quality of life between android and gynoid postmenopausal women
Time Frame: Baseline
Menopause Rating Scale (MRS): somatic symptoms; psychological symptoms; urogenital-sexual problems
Baseline
Comparison of the body composition between android and gynoid postmenopausal women
Time Frame: Baseline
Body composition: bipolar electrical bioimpedance (body fat and lean mass) and skinfolds (triceps, subscapular, suprailiac, abdominal, anterior thigh, medial calf)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Audrey Borghi-Silva, Ph.D, Department of Physical Therapy, Federal University of São Carlos (UFSCar)
  • Principal Investigator: Fernanda R. Paolillo, Ph.D, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (Estimate)

December 7, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 150949/2011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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