Study of cardiac and metabolic control in women with polycystic ovary syndrome

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4qsf57
• Date of registration: 14/07/2014
• Prospective Registration: No
• Primary sponsor: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Public title: Study of cardiac and metabolic control in women with polycystic ovary syndrome
• Scientific title: Correlation study of the adaptations into cardiac autonomic modulation and metabolic parameters in women with polycystic ovary syndrome submitted to aerobic training
• Date of first enrolment: 05/01/2010
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4qsf57
• Study type: Intervention
• Study design: Prospective trial of treatment of one arm.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Ana Paula Manfio Pereira
• Affiliation: Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

• Name: Ana Paula Manfio Pereira
• Affiliation: Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Women aged between 18 and 40 healthy years and diagnosed with polycystic ovarian syndrome belonging to the outpatient clinic of Gynecology and Obstetrics of the University were not engaged in regular physical activity (least 2 times per week)
Exclusion criteria: Exclusion criteria: women in use of contraceptives or other drug treatment, smoker (regular consumption of cigarettes or tobacco-derived.); alcoholic (physical and psychological dependence on alcohol); who had mental disorders that hindered the understanding and execution of tests; disabling musculoskeletal disorders (osteoporosis, fractures unconsolidated, muscular dystrophy, low back pain) and cardiovascular disease (myocardial infarction, heart failure, arrhythmias).

Age minimum: 18Y
Age maximum: 40Y
Gender: F

Health Condition(s) or Problem(s) studied

Polycystic ovary syndrome, cardiac autonomic modulation, body mass index, adipokines.

C04.182.612.765

Intervention(s)

Polycystic Ovary Syndrome untreated (PCOS group, n=60) and control group without the syndrome (control group, n=60): 120 women (33 ± 3 years) who were divided into two groups were studied. Each group was divided into three smaller groups (n=20) according to the percentage of body fat (22-27%, 27-32% and 32-37%) assessed by bioelectrical impedance method.
All subjects underwent a protocol of physical training with 16 weeks duration , intensity adjusted to 90 % of heart rate (HR) obtained in anaerobic threshold through the cardiopulmonary exercise test. The protocol was performed supervised aerobic training on treadmill four to five times per week with duration of 60 minutes per session, with monitoring of blood pressure and heart rate.
 The volunteers were subjected to the initial and final evaluation (the physical training protocol) which consisted of analysis of body composition (bioelectrical impedance analysis), heart rate variability ,glucose, insulin and metabolic markers (leptin, adiponectin, tumor necrosis factor -alpha and interleukin -6).

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Other

Primary Outcome(s)

The program of aerobic exercise training in PCOS group promoted beneficial on many factors evaluated effects, such as increased adiponectin and decreased interleukin-6 and TNF-alpha, however, its greatest effects were on glucose tolerance, fasting insulin and leptin.

Women with Polycystic Ovary Syndrome (PCOS)may exhibit decreased sympathetic influence and increased parasympathetic activity as assessed by spectral analysis of heart rate and comparing pre and post program of aerobic exercise training conditions.

Women with PCOS may experience metabolic changes, measured through blood samples and tests specific radioimmunoassay, as increased fasting glycemia (blood glucose> 110mg/dL); reduced insulin sensitivity observed in the glucose tolerance test of 75gramas (value of glycemia> 140mg/dl after 2 hours); increasing blood levels of leptin (blood dosage> 17ng/mL), interleukin-6 (blood dosage> 5 pg / mL) and factor-alpha tumor necrosis factor (blood dosage> 8 pg / ml), and decreased levels of adiponectin (reference value of blood: 5-30 mg / mL) and these variables influenced by aerobic exercise training program.

Women with PCOS and women in the control group showed no differences in autonomic modulation in the evaluation of spectral analysis of heart rate after aerobic exercise training program.

Secondary Outcome(s)

Increased body fat may alter the autonomic modulation and metabolic markers after the exercise training program. For this, the PCOS group and the control group were divided into 3 subgroups each, according to the percentage of body fat (22-27%, 27-32% and 32-37%) assessed by bioelectrical impedance.

The program of aerobic exercise training caused a decrease in blood glucose levels of the PCOS groups with higher percentages of body fat (27-32% and 32-37%), values ??similar to those observed in the group with lower body fat percentage (22 - 27%). As for the values ??of leptin, all groups decreased after training, however the SOP group trained with greater body fat percentage (32-37%) showed higher values ??than the other. Regarding adiponectin, aerobic exercise training promoted an increase in the groups with higher percentages of body fat, generating similar values ??among all trained groups. Finally, analysis of IL-6 after exercise training showed that the group with the highest percentage of body fat declined significantly, however, this group also showed higher values ??compared to the other groups also trained.

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Secondary Sponsor(s)

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo