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Moran L.J.,University of Adelaide | Moran L.J.,Monash University | Norman R.J.,University of Adelaide | Teede H.J.,University of Adelaide | And 2 more authors.
Trends in Endocrinology and Metabolism | Year: 2015

Polycystic ovary syndrome (PCOS) is a common condition in reproductive-aged women, with reproductive, cardiometabolic, and psychological features. The heterogeneity in insulin resistance, obesity, and cardiometabolic features has led to controversy on the independent contributions of PCOS status, diagnostic criteria, phenotype, and adiposity. It now appears that women with PCOS have an increased risk of insulin resistance and cardiometabolic features, which is independent of, but worsened by, adiposity and central adiposity, and is unrelated to reproductive phenotype. Obesity may be more prevalent in the more severe phenotypes, which suggests either an exacerbation of the reproductive features or a more likely diagnosis in overweight women with PCOS. Therefore, all women with PCOS should be targeted for prevention, screening, and management of cardiometabolic features. © 2014 Elsevier Ltd.


Naderpoor N.,Monash University | Naderpoor N.,Diabetes and Vascular Medicine Unit | Shorakae S.,Monash University | Shorakae S.,Diabetes and Vascular Medicine Unit | And 8 more authors.
Human Reproduction Update | Year: 2015

Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder with diverse reproductive and metabolic features. It is underpinned by insulin resistance that is exacerbated by obesity. Lifestyle modification is the first line treatment in PCOS, but it is associated with lowadherence and sustainability. In small studies, metformin improves outcomes such as hyperinsulinaemia, ovulation and menstrual cyclicity. We conducted a systematic review and meta-analysis to compare the effect of lifestyle modification + metformin with lifestyle modification ± placebo, and of metformin alone with lifestyle modification ± placebo in PCOS on anthropometric, metabolic, reproductive and psychological outcomes. Methods: Databases including MEDLINE, EMBASE, Pubmed, Scopus, Cochrane, PsycINFO, CINAHL, Clinical Trials registry and ANZCTR were searched for RCTs conducted on humans and published in English up to August 2014. Inclusion criteria were diagnosis of PCOS based on Rotterdam criteria (inclusive of National Institutes of Health criteria) at any age and with any BMI. Interventions of interest included lifestyle + metformin (with any dose and any duration) or metformin alone compared with lifestyle ± placebo. Results: Of 2372 identified studies, 12 RCTs were included for analysis comprising 608 women with PCOS. Lifestyle + metformin were associated with lowerBMI (mean difference (MD) 20.73 kg/m2, 95%confidence intervals (CI) 21.14, 20.32, P = 0.0005) and subcutaneous adipose tissue (MD 292.49 cm2, 95%CI 2164.14, 220.84, P 1/4 0.01) and increased number of menstrual cycles (MD1.06, 95%CI 0.30, 1.82, P 1/4 0.006) after 6 months compared with lifestyle ± placebo. There were no differences in other anthropometric, metabolic (surrogate markers of insulin resistance, fasting and area under the curve glucose, lipids and blood pressure), reproductive (clinical and biochemical hyperandrogenism), and psychological (quality of life) outcomes after 6 months between lifestyle + metformin compared with lifestyle ± placebo.With metformin alone compared with lifestyle ± placebo, weight and BMI were similar after 6 months, but testosterone was lower with metformin. Conclusion: Lifestyle ± metformin is associated with lower BMI and ubcutaneous adipose tissue and mproved menstruation in women with PCOS compared with ifestyle ± placebo over 6 months. etformin alone compared with ifestyle showed similar BMI at 6 months. These results suggest the combination of ifestyle with metformin has a role to play in weight Management: a key oncern for women with PCOS. Existing study limitations include small sample sizes, short durations and risk of ias. With international guidelines ow acknowledging that lifestyle and pharmacotherapy are required for eight loss and maintenance in besity, future studies of appropriate size and duration are vital to clarify the role of metformin in PCOS management. © The Author 2015. Published by Oxford University Press.


Teede H.,Monash University | Teede H.,Diabetes and Vascular Medicine Unit | Gibson-Helm M.,Monash University | Norman R.J.,University of Adelaide | Boyle J.,Monash University
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Context: Polycystic ovary syndrome (PCOS) is an under-recognized, common, and complex endocrinopathy. The name PCOS is a misnomer, and there have been calls for a change to reflect the broader clinical syndrome. Objective: The aim of the study was to determine perceptions held by women and primary health care physicians around key clinical features of PCOS and attitudes toward current and alternative names for the syndrome. Design: We conducted a cross-sectional study utilizing a devised questionnaire. Setting: Participants were recruited throughout Australia via professional associations, women's health organizations, and a PCOS support group. Participants: Fifty-seven women with PCOS and 105 primary care physicians participated in the study. Main Outcome Measures: Perceptions of key clinical PCOS features and attitudes toward current and alternative syndrome names were investigated. Results: Irregular periods were identified as a key clinical feature of PCOS by 86% of the women with PCOS and 90% of the primary care physicians. In both groups, 60% also identified hormone imbalance as a key feature. Among women with PCOS, 47% incorrectly identified ovarian cysts as key, 48% felt the current name is confusing, and 51% supported a change. Most primary care physicians agreed that the name is confusing (74%) and needs changing (81%); however, opinions on specific alternative names were divided. Conclusions: The name "polycystic ovary syndrome" is perceived as confusing, and there is general support for a change to reflect the broader clinical syndrome. Engagement of primary health care physicians and consumers is strongly recommended to ensure that an alternative name enhances understanding and recognition of the syndrome and its complex features. (J Clin Endocrinol Metab 99: E107-E111, 2014). © Copyright 2014 by The Endocrine Society.


Gibson-Helm M.,Monash University | Boyle J.,Monash University | Block A.,Refugee Health Service | Teede H.,Monash University | Teede H.,Diabetes and Vascular Medicine Unit
BMC Medical Research Methodology | Year: 2014

Background: Routine public health databases contain a wealth of data useful for research among vulnerable or isolated groups, who may be under-represented in traditional medical research. Identifying specific vulnerable populations, such as resettled refugees, can be particularly challenging; often country of birth is the sole indicator of whether an individual has a refugee background. The objective of this article was to review strengths and weaknesses of different methodological approaches to identifying resettled refugees and comparison groups from routine health datasets and to propose the application of additional methodological rigour in future research. Discussion. Methodological approaches to selecting refugee and comparison groups from existing routine health datasets vary widely and are often explained in insufficient detail. Linked data systems or datasets from specialized refugee health services can accurately select resettled refugee and asylum seeker groups but have limited availability and can be selective. In contrast, country of birth is commonly collected in routine health datasets but a robust method for selecting humanitarian source countries based solely on this information is required. The authors recommend use of national immigration data to objectively identify countries of birth with high proportions of humanitarian entrants, matched by time period to the study dataset. When available, additional migration indicators may help to better understand migration as a health determinant. Methodologically, if multiple countries of birth are combined, the proportion of the sample represented by each country of birth should be included, with sub-analysis of individual countries of birth potentially providing further insights, if population size allows. United Nations-defined world regions provide an objective framework for combining countries of birth when necessary. A comparison group of economic migrants from the same world region may be appropriate if the resettlement country is particularly diverse ethnically or the refugee group differs in many ways to those born in the resettlement country. Summary. Routine health datasets are valuable resources for public health research; however rigorous methods for using country of birth to identify resettled refugees would optimize usefulness of these resources. © 2014 Gibson-Helm et al.; licensee BioMed Central Ltd.


Joham A.E.,Monash University | Joham A.E.,Diabetes and Vascular Medicine Unit | Boyle J.A.,Monash University | Ranasinha S.,Monash University | And 4 more authors.
Human Reproduction | Year: 2014

STUDY QUESTIONDo contraception use, pregnancy outcome and number of children differ in women with and without polycystic ovary syndrome (PCOS)?SUMMARY ANSWERWomen with PCOS were less likely to report use of contraception and more likely to report a miscarriage, whilst number of children was similar between groups.WHAT IS KNOWN ALREADYThe oral contraceptive pill is used in the management of PCOS, but the patterns of contraception use in women with PCOS is not known. In women with PCOS who undergo assisted reproduction, the risk of pregnancy loss appears higher, yet pregnancy loss and family size among community-based women with PCOS is not known.STUDY DESIGN, SIZE AND DURATIONThis is a cross-sectional analysis of a longitudinal cohort study. Mailed survey data were collected at five time points (years 1996, 2000, 2003, 2006 and 2009). Data from respondents to Survey 4 (2006), aged 28-33 (n = 9145, 62% of the original cohort aged 18-23 years) were analysed.PARTICIPANTS/ MATERIALS, SETTING, METHODSThis study was conducted in a general community setting. Data from participants who responded to the questions on PCOS, contraception and pregnancy outcome were analysed. The main outcome measures were self-reported PCOS, body mass index (BMI), contraception use, pregnancy loss and number of children.MAIN RESULTS AND THE ROLE OF CHANCEIn women aged 28-33 years, women with PCOS were less likely to be using contraception (61 versus 79%, P < 0.001) and more likely to be trying to conceive (56 versus 45%, P < 0.001), compared with women not reporting PCOS. A greater proportion of women with PCOS reported pregnancy loss (20 versus 15%, P = 0.003). PCOS was not independently associated with pregnancy loss; however, BMI was independently associated with pregnancy loss in the overweight and obese groups (OR 1.2, 95% CI 1.04-1.4, P = 0.02 and OR 1.4, 95% CI 1.1-1.6, P = 0.001, respectively). Fertility treatment use was also independently associated with pregnancy loss (adjusted OR 3.2, 95% CI 2.4-4.2, P < 0.001). There was no significant difference in number of children between women with and without PCOS.LIMITATIONS, REASON FOR CAUTIONPCOS, contraception use and pregnancy outcome data were self-reported. Attrition occurred, but is reasonable compared with similar longitudinal cohort studies.WIDER IMPLICATIONS OF THE FINDINGSThis community-based cohort aged 28-33 years provides insights into the contraceptive use, pregnancy loss and family size of a large cohort of unselected women. Women reporting PCOS had lower rates of contraception use and were more likely to be currently trying to conceive, suggesting that they may be aware of potential fertility challenges, yet in those not planning to conceive, contraceptive use was low and further education may be required. Despite prior reports of higher rates of pregnancy loss in PCOS, usually from infertility services, in this community-based population, PCOS was not independently associated with pregnancy loss, yet independent risk factors for pregnancy loss included higher BMI, were higher in PCOS. The number of children per woman was similar in the both groups, albeit with more infertility treatment in PCOS. This may reassure women with PCOS that with access to fertility treatment, family sizes appear similar to women not reporting PCOS.STUDY FUNDING/COMPETING INTERESTThis epidemiological research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. A.E.J. is an NHMRC postgraduate scholarship holder, H.J.T. and J.A.B. are NHMRC postdoctoral research fellows and S.Z. is a NHF postdoctoral research fellow. The ALSWH is funded by the Australian Government Department of Health and Ageing. The authors declare that there is no conflict of interest associated with this manuscript. © The Author 2014.


Stepto N.K.,Victoria University of Melbourne | Stepto N.K.,Monash University | Cassar S.,Victoria University of Melbourne | Joham A.E.,Monash University | And 5 more authors.
Human Reproduction | Year: 2013

Study Question: What is the prevalence of insulin resistance (IR) and the contributions of intrinsic and extrinsic IR in women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria? Summary Answer: We report novel clamp data in Rotterdam diagnosed PCOS women, using World Health Organization criteria for IR showing that women with PCOS have a high prevalence of IR, strengthening the evidence for an aetiological role of IR in both National Institutes of Health (NIH) and Rotterdam diagnosed PCOS in lean and overweight women. What is Known Already: PCOS is a complex endocrine condition with a significant increased risk of gestational diabetes and type 2 diabetes. Study Design , Size, Duration Using a cross-sectional Study Design , 20 overweight and 20 lean PCOS (Rotterdam criteria), 14 overweight and 19 lean body mass index (BMI)-matched control non-PCOS women underwent clinical measures of IR after a 3-month withdrawal of insulin sensitizers and the oral contraceptive pill.MATERIALS, SETTING, METHODSIn an academic clinic setting, glucose infusion rate (GIR) on euglycaemic-hyperinsulinaemic clamp was investigated as a marker of insulin sensitivity. Main Results and the Role of Chance: PCOS women were more IR than BMI-matched controls (main effect for BMI and PCOS; P < 0.001). IR was present in 75% of lean PCOS, 62% of overweight controls and 95% of overweight PCOS. Lean controls (mean ± SD; GIR 339 ± 76 mg min-1 m-2) were less IR than lean PCOS (270 ± 66 mg min-1 m-2), overweight controls (264 ± 66 mg min-1 m-2) and overweight PCOS (175 ± 96 mg min-1 m-2). The negative relationship between BMI and IR reflected by GIR was more marked in PCOS (y = 445.1-7.7x, R2 = 0.42 (P < 0.0001) than controls (y = 435.5-4.6x, R2 = 0.04 (P < 0.01)). Limitations, Reasons For Caution The study did not use glucose tracer techniques to completely characterize the IR, as well as the lack of matching for body composition and age. Wider Implications of the Finding: s: IR is exacerbated by increased BMI, supporting intrinsic IR in PCOS. BMI impact on IR is greater in PCOS, than in controls, irrespective of visceral fat, prioritizing lifestyle intervention and the need for effective therapeutic interventions to address intrinsic IR and prevent diabetes in this high-risk population. Study Funding/Competing Interes: T(S)This investigator-initiated trial was supported by grants from the National Health & Medical Research Council (NHMRC) Grant number 606553 (H.J.T., N.K.S. and S.K.H.) as well as Monash University and The Jean Hailes Foundation. H.J.T. is an NHMRC Research Fellow. N.K.S. is supported through the Australian Government's Collaborative Research Networks (CRN) programme. A.E.J. is a Jean Hailes and NHMRC scholarship holder. The authors declare that there is no conflict of interest associated with this manuscript. Clinical Trial Registrationisrctn 84763265. © 2013 The Author.


Lombard C.B.,Monash University | Harrison C.L.,Monash University | Kozica S.L.,Monash University | Zoungas S.,Monash University | And 3 more authors.
BMC Public Health | Year: 2014

Background: To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Methods. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Discussion. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally. Trial registration. ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012. © 2014 Lombard et al.; licensee BioMed Central Ltd.


Lombard C.,Monash University | Harrison C.,Monash University | Kozica S.,Monash University | Zoungas S.,Monash University | And 4 more authors.
PLoS Medicine | Year: 2016

Background: Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information. Methods and Findings: We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters) randomised using a computer-generated randomisation list for intervention (n = 21) or control (n = 20). Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her) consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women’s health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/− SD 6.7) and BMI of 28.8 kg/m2 (+/− SD 6.9) with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI −0.09 to 0.97) and in the intervention group −0.48kg (95% CI −0.99 to 0.03) with an unadjusted between group difference of −0.92 kg (95% CI −1.67 to −0.16) or −0.87 kg (95% CI −1.62 to −0.13) adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures. Conclusions: A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included community integration, nonprescriptive simple health messages, small changes to behaviour, low participant burden, self-weighing, and delivery including a mix of group, phone, and SMS text reminders. The findings support population strategies to halt the rise in obesity prevalence. © 2016 Lombard et al.


Harrison C.L.,Monash University | Lombard C.B.,Monash University | Teede H.J.,Monash University | Teede H.J.,Diabetes and Vascular Medicine Unit
International Journal of Behavioral Nutrition and Physical Activity | Year: 2014

Background: Pregnancy is a recognised high risk period for excessive weight gain, contributing to postpartum weight retention and obesity development long-term. We aimed to reduce postpartum weight retention following a low-intensity, self-management intervention integrated with routine antenatal care during pregnancy. Methods: 228 women at increased risk of gestational diabetes, <15 weeks gestation were randomised to intervention (4 self-management sessions) or control (generic health information). Outcomes, collected at baseline and 6 weeks postpartum, included anthropometrics (weight and height), physical activity (pedometer) and questionnaires (health behaviours). Results: Mean age (32.3 ± 4.7 and 31.7 ± 4.4 years) and body mass index (30.4 ± 5.6 and 30.3 ± 5.9 kg/m2) were similar between intervention and control groups, respectively at baseline. By 6 weeks postpartum, weight change in the control group was significantly higher than the intervention group with a between group difference of 1.45 ± 5.1 kg (95% CI: -2.86,-0.02; p < 0.05) overall, with a greater difference in weight found in overweight, but not obese women. Intervention group allocation, higher baseline BMI, GDM diagnosis, country of birth and higher age were all independent predictors of lower weight retention at 6 weeks postpartum on multivariable linear regression. Other factors related to weight including physical activity, did not differ between groups. Conclusions: A low intensity intervention, integrated with standard antenatal care is effective in limiting postpartum weight retention. Implementation research is now required for scale-up to optimise antenatal health care. Trial registration: Australian New Zealand Clinical Trial Registry Number: ACTRN12608000233325. Registered 7/5/2008.


Hipkiss A.R.,Aston University | Baye E.,Monash Center for Health Research and Implementation | de Courten B.,Monash Center for Health Research and Implementation | de Courten B.,Diabetes and Vascular Medicine Unit
Maturitas | Year: 2016

The causes of ageing are usually regarded as multifactorial; thus effective regulation might be achieved by intervention at multiple sites. It has been suggested that the endogenous dipeptide carnosine, also available as a food supplement, possesses anti-ageing activity and may achieve its reported age-alleviating effects via a number of mechanisms. Carnosine's possible anti-ageing mechanisms are therefore discussed; the evidence suggests that inhibition of the mechanistic target of rapamycin and carbonyl scavenging may be involved. © 2016 Elsevier Ireland Ltd

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