Postmenopausal DisorderNCT01745042
Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women
An observational study of Postmenopausal Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and symptomatic profiles in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- Clinical exams
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Postmenopausal women from a community sample of São Carlos city - São Paulo State - Brazil.
Who may be able to join
- Postmenopausal women
- Caucasian
- 50-60 years of age
Who cannot join
- Neurological disease
- Pulmonary disease
- Cardiac disease
- Oncological disease
- Musculotendinous or articular injuries
- Hormone replacement therapy
- Cigarette smoking
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
São Carlos, São Paulo, 676
About this study
Official title: 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.
Read the 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.
- Conditions
- Postmenopausal Disorder
- Being tested
- Clinical exams
- Keywords
- Postmenopausal Women, Body Composition, Metabolic Syndrome, Menopause Symptoms
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examsOther
Physiological and biochemical tests; quality of life questionnaire; body composition measurement
| Study group | Role | What they receive |
|---|---|---|
| android postmenopausal women | Clinical exams Receives: Other: Clinical exams | |
| gynoid postmenopausal women | Clinical exams Receives: Other: Clinical exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationships between postmenopause and fat distribution
Anthropometric measurements: waist-to-hip ratio and body mass index
Measured: Baseline
Secondary outcomes (4)
Comparison of aerobic capacity between android and gynoid postmenopausal women
Progressive aerobic testing on treadmill (Modified Bruce Protocol): estimated maximum oxygen consumption; metabolic equivalents; blood pressure; heart rate
Measured: Baseline
Comparison of metabolic parameters between android and gynoid postmenopausal women
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
Measured: Baseline
Comparison of quality of life between android and gynoid postmenopausal women
Menopause Rating Scale (MRS): somatic symptoms; psychological symptoms; urogenital-sexual problems
Measured: Baseline
Comparison of the body composition between android and gynoid postmenopausal women
Body composition: bipolar electrical bioimpedance (body fat and lean mass) and skinfolds (triceps, subscapular, suprailiac, abdominal, anterior thigh, medial calf)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- 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.
- Responsible party
- Principal investigator, Fernanda Rossi Paolillo, University of Sao Paulo
- Investigators
- Audrey Borghi-Silva, Ph.D, Study director, Department of Physical Therapy, Federal University of São Carlos (UFSCar)Cristina Kurachi, Ph.D, Study director, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Vanderlei S Bagnato, Ph.D, Study director, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Fernanda R. Paolillo, Ph.D, Principal investigator, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745042
- Sponsor's protocol ID
- 150949/2011-1
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22089183Paolillo 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.
PubMed 21749263Paolillo 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.
PubMed 22382875Blumel 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.
PubMed 22067278Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
PubMed 17167477
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fat Distribution on Metabolic, Cardiovascular and Symptomatic Aspects in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01745042
- Acronym / sponsor ID
- 150949/2011-1
- Conditions
- Postmenopausal Disorder
- Keywords
- Postmenopausal Women, Body Composition, Metabolic Syndrome, Menopause Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- 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.
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate anthropometric, metabolic, cardiovascular and symptomatic profiles in postmenopausal women.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| android postmenopausal women | – | Other: Clinical examsClinical exams |
| gynoid postmenopausal women | – | Other: Clinical examsClinical exams |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Postmenopausal women from a community sample of São Carlos city - São Paulo State - Brazil.
Key inclusion criteria (3 listed)
- Postmenopausal women
- Caucasian
- 50-60 years of age
Key exclusion criteria (7 listed)
- Neurological disease
- Pulmonary disease
- Cardiac disease
- Oncological disease
- Musculotendinous or articular injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examsPhysiological and biochemical tests; quality of life questionnaire; body composition measurement | Other | android postmenopausal women, gynoid postmenopausal women |
Primary outcome
Relationships between postmenopause and fat distribution
Time frame: Baseline
Anthropometric measurements: waist-to-hip ratio and body mass index
4 secondary outcomes
Comparison of aerobic capacity between android and gynoid postmenopausal women
Time frame: Baseline
Comparison of metabolic parameters between android and gynoid postmenopausal women
Time frame: Baseline
Comparison of quality of life between android and gynoid postmenopausal women
Time frame: Baseline
Comparison of the body composition between android and gynoid postmenopausal women
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
- Background: PubMed 22089183Paolillo 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.
- Background: PubMed 21749263Paolillo 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.
- Background: PubMed 22382875Paolillo 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.
- Background: PubMed 22067278Blumel 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.
- Background: PubMed 17167477Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Borghi-Silva, Ph.D study director
Department of Physical Therapy, Federal University of São Carlos (UFSCar)
Cristina Kurachi, Ph.D study director
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Vanderlei S Bagnato, Ph.D study director
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Disorder, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationships between postmenopause and fat distribution (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745042, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2012.