Anthropometric, Metabolic, Cardiovascular and Symptomatic Profile in Postmenopausal Women

Postmenopausal Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745042
• Other study ID #: 150949/2011-1
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: December 5, 2012
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Postmenopausal Disorder

Intervention

Other:
• Clinical exams
Physiological and biochemical tests; quality of life questionnaire; body composition measurement

Locations

Country	Name	City	State
Brazil	Optics Group from Physics Institute of São Carlos (IFSC), University of São Paulo (USP)	São Carlos	São Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	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

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Blümel 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, Zuñiga 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. — View Citation

Després JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationships between postmenopause and fat distribution	Anthropometric measurements: waist-to-hip ratio and body mass index	Baseline	Yes
Secondary	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	Baseline	Yes
Secondary	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	Baseline	Yes
Secondary	Comparison of quality of life between android and gynoid postmenopausal women	Menopause Rating Scale (MRS): somatic symptoms; psychological symptoms; urogenital-sexual problems	Baseline	Yes
Secondary	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)	Baseline	Yes