- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745042
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
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.
Sponsor
Collaborators
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
- Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- 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.
- 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.
- 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.
- 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.
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.
Clinical Trials on Postmenopausal Disorder
-
YI-JU TSAIRecruitingMenopause | Postmenopausal | Postmenopausal DisorderTaiwan
-
Cairo Universityfaculty of physical therapyCompletedPostmenopausal DisorderEgypt
-
Chong Kun Dang PharmaceuticalSeverance HospitalCompleted
-
Fundació EurecatCompletedMenopause | Postmenopausal Symptoms | Postmenopausal DisorderSpain
-
National Taiwan University HospitalCompleted
-
Riphah International UniversityCompletedPostmenopausal DisorderPakistan
-
Puerta de Hierro University HospitalCompletedPostmenopausal DisorderSpain
-
Yaounde Central HospitalCompletedHypertension | Postmenopausal DisorderCameroon
-
Azienda di Servizi alla Persona di PaviaRecruiting
-
University of ValenciaRecruitingMenopause | Postmenopausal Symptoms | Climacteric Syndrome | Perimenopausal DisorderSpain
Clinical Trials on Clinical exams
-
Washington University School of MedicineRecruiting
-
National Institute of Neurological Disorders and...Recruiting
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Hanyang UniversityCompletedChronic Kidney Diseases | Hemolysis
-
Massachusetts General HospitalDana-Farber Cancer InstituteTerminated
-
University of Rome Tor VergataRecruitingAcute Lymphoblastic LeukemiaItaly
-
Hôpital Edouard HerriotCompletedDigestive System DiseaseFrance
-
University Hospital, LimogesUnknown
-
Hospices Civils de LyonActive, not recruiting
-
University Hospital, BordeauxCompletedAge-related Macular Degeneration | Elderly French PopulationFrance