CompletedPhase 4ACTRN12606000198527

Weight loss and exercise in PCOS Study 2006

Effects of exercise and lifestyle management on reproductive function in overweight women with polycystic ovary syndrome


Sponsor

CSIRO Human Nutrition

Enrollment

90 participants

Start Date

Jun 19, 2006

Study Type

Interventional

Conditions

Summary

Australia and other Western communities face an “epidemic of obesity” among its people, particularly in the young. The health problems of obesity include diabetes mellitus, hyperlipidemia, micro- and macrovascular disease, disability and early death. Major public health interventions are required in Australia to reverse this serious and expensive trend. This is particularly true in young overweight women with polycystic ovary syndrome (PCOS) who have significant psychological, reproductive and metabolic consequences during the first five decades of life. Although research indicates that weight loss via dietary restriction can restore health and reverse the reproductive and metabolic consequences of PCOS, there is a lack of scientific understanding of the combined role of physical exercise in managing this condition. Furthermore, there remains no attempt to define the optimal mode of exercise to achieve long-term reproductive fitness and metabolic health and consequently a lack of exercise recommendations for this population exists. The overall significance of this research proposal is to provide scientific evidence for the effects of physical exercise combined with dietary weight loss to improve ovulatory rates and reproductive health in overweight women with PCOS. This study will also provide information on what, if any, is the most efficacious form of exercise for improving reproductive function in this patient group. This information will assist in the development and refinement of guidelines for managing PCOS through lifestyle behavioural change. Precise guidelines would be of great use for firstly improving conception rates through improvements in the metabolic state and secondly through minimising longer term diabetic and cardiovascular mortality and morbidity. Systematic study of the effects of exercise and variants of its modalities in combination with dietary change is imperative in order to make appropriate public health recommendation and to counsel individual patients.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria3

  • Overweight or obese PCOS
  • Generally healthy with no chronic or acute diseases or disorders
  • Not pregnant or breast feeding.

Exclusion Criteria1

  • Known cardiovascular disease, current smoking, diabetes mellitus uncontrolled hypertension, proteinuria, a malignancy, a history of liver, kidney or respiratory disease, or are pregnantUnrelated reproductive disorders. thyroid abnormalities (hypo- and hyperthyroidism), non-classic adrenal hyperplasia as assessed by fasting or acetylthiocholine (ATCH)-stimulated serum 17-hydroxyprogesterone).Fertility treatment such as clomiphene citrate or In-Vitro Fertilisation (IVF), insulin-sensitising agents (participation will be allowed upon discontinuation of therapy for one month prior to intervention).Oral contraceptive use (participation will be allowed upon discontinuation of oral contractive therapy one month prior to intervention). Participations will be required to use barrier contraception throughout the study intervention.

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Interventions

Participants will be randomly assigned for the 20 week intervention to either: (2) energy restrictive diet (6000kj: carbohydrate 40% total energy, protein 30%, fat 30%) and aerobic exercise (45 to

Participants will be randomly assigned for the 20 week intervention to either: (2) energy restrictive diet (6000kj: carbohydrate 40% total energy, protein 30%, fat 30%) and aerobic exercise (45 to 60 minutes:5 times per week) or (3) energy restrictive diet (6000kj: carbohydrate 40% total energy, protein 30%, fat 30%) and combined aerobic training (45-60 minutes: 3 times per week) and strength training (twice per week)


Locations(1)

Australia

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