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Completed

NCT Number: NCT01745042

Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women

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

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Key information

Conditions

Postmenopausal Disorder Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

50 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

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

São Carlos, São Paulo, 676, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical exams

Other

Physiological and biochemical tests; quality of life questionnaire; body composition measurement

Primary outcomes

  1. Relationships between postmenopause and fat distribution

    Time frame: Baseline

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 7, 2012
Registry last updated
Dec 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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