NCT01745042

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

December 3, 2012

Last Update Submit

December 5, 2012

Conditions

Keywords

Postmenopausal WomenBody CompositionMetabolic SyndromeMenopause Symptoms

Outcome Measures

Primary Outcomes (1)

  • Relationships between postmenopause and fat distribution

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

    Baseline

Secondary Outcomes (4)

  • Comparison of aerobic capacity between android and gynoid postmenopausal women

    Baseline

  • Comparison of metabolic parameters between android and gynoid postmenopausal women

    Baseline

  • Comparison of quality of life between android and gynoid postmenopausal women

    Baseline

  • Comparison of the body composition between android and gynoid postmenopausal women

    Baseline

Study Arms (2)

android postmenopausal women

Clinical exams

Other: Clinical exams

gynoid postmenopausal women

Clinical exams

Other: Clinical exams

Interventions

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

android postmenopausal womengynoid postmenopausal women

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Postmenopausal women
  • Caucasian
  • years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Carlos, São Paulo, 676, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 22089183BACKGROUND
  • 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.

    PMID: 21749263BACKGROUND
  • 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.

    PMID: 22382875BACKGROUND
  • 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.

    PMID: 22067278BACKGROUND
  • Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.

    PMID: 17167477BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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)

    STUDY DIRECTOR
  • Fernanda R. Paolillo, Ph.D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Federal University of São Carlos

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 7, 2012

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 7, 2012

Record last verified: 2012-12

Locations