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OR31-01 A Randomized Controlled Trial of a Lifestyle Intervention with Longitudinal Follow up on Ovarian Dysmorphology, Hyperandrogenism, and Menstrual Irregularity in Women with Polycystic Ovary Syndrome

ABSTRACT: Abstract The recent International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome (PCOS) recommended healthy lifestyle interventions (dietary, exercise, behavioral modification, or combined) as the first-line therapy to mediate favorable metabolic outcomes in PCOS. However, the relationship between lifestyle modifications and reproductive health in PCOS is less clear. Specifically, a favorable dietary composition to facilitate reproductive changes in women with PCOS remains unknown. Further, the longitudinal impacts of lifestyle change programs in women with PCOS is poorly elucidated. We hypothesized that a low glycemic index pulse-based diet containing lentils, beans, split peas, and chickpeas would be more effective than the Therapeutic Lifestyle Changes (TLC) diet at improving insulin sensitivity without an energy-restricted protocol and would improve reproductive health outcomes in women with PCOS after a 16-week intervention. Our objective was to compare the effects of a nutritionally balanced pulse-based diet with the TLC diet on ultrasonographic markers of ovarian morphology, hyperandrogenism, and menstrual irregularity. Women (n=30) randomized to the pulse-based and TLC (n=31) groups completed a 16-week intervention. All women participated in aerobic exercise (minimum 5 days/week; 45 minutes/day) and received health counseling (monthly) about PCOS and the benefits of lifestyle modification. Additionally, we evaluated the effects of the intervention on the reproductive outcomes by longitudinal follow-up of all participants. Follicle numbers per ovary (FNPO, 2-9 mm), ovarian volume (OV), free androgen index (FAI), intermenstrual intervals, and insulin sensitivity (Matsuda index and homeostasis model assessment of insulin resistance [HOMA-IR] were evaluated at baseline, 16-week post-intervention, and 6- and 12-month post-intervention follow up visits. Follicle numbers per ovary (mean change ± SD, -10 ± 15), OV (-2.7 ± 4.8 mL), FAI (-3 ± 2), intermenstrual interval (-13 ± 47 days), and body mass index (BMI, -1.6 ± 4.2 kg/m2) decreased, and Matsuda index (1.1 ± 3.1) increased over time in both groups (All: P ? 0.01), without group-by-time interactions (All: P ? 0.27). Groups maintained reduced OV, FNPO, FAI, and menstrual cycles 6 months post-intervention, despite a propensity for weight regain as evidenced by increased BMI (1.0 ± 4.8 kg/m2; P < 0.01). Decreased FNPO, FAI, and HOMA-IR at 16-week tended to revert to baseline levels 12 months post-intervention in both groups (All: P ? 0.05). Both interventions improved ovarian dysmorphology, hyperandrogenism, and menstrual irregularity in women with PCOS. Our observations elucidate the importance of longitudinal surveillance for sustainable adherence to newly adopted healthy lifestyle behaviors and reproductive health in PCOS (ClinicalTrials.gov identifier, NCT01288638).

SUBMITTER: Kazemi M

PROVIDER: S-EPMC7209505 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Project description:Polycystic ovary syndrome (PCOS) was hypothesized to result from functional ovarian hyperandrogenism (FOH) due to dysregulation of androgen secretion in 1989-1995. Subsequent studies have supported and amplified this hypothesis. When defined as otherwise unexplained hyperandrogenic oligoanovulation, two-thirds of PCOS cases have functionally typical FOH, characterized by 17-hydroxyprogesterone hyperresponsiveness to gonadotropin stimulation. Two-thirds of the remaining PCOS have FOH detectable by testosterone elevation after suppression of adrenal androgen production. About 3% of PCOS have a related isolated functional adrenal hyperandrogenism. The remaining PCOS cases are mild and lack evidence of steroid secretory abnormalities; most of these are obese, which we postulate to account for their atypical PCOS. Approximately half of normal women with polycystic ovarian morphology (PCOM) have subclinical FOH-related steroidogenic defects. Theca cells from polycystic ovaries of classic PCOS patients in long-term culture have an intrinsic steroidogenic dysregulation that can account for the steroidogenic abnormalities typical of FOH. These cells overexpress most steroidogenic enzymes, particularly cytochrome P450c17. Overexpression of a protein identified by genome-wide association screening, differentially expressed in normal and neoplastic development 1A.V2, in normal theca cells has reproduced this PCOS phenotype in vitro. A metabolic syndrome of obesity-related and/or intrinsic insulin resistance occurs in about half of PCOS patients, and the compensatory hyperinsulinism has tissue-selective effects, which include aggravation of hyperandrogenism. PCOS seems to arise as a complex trait that results from the interaction of diverse genetic and environmental factors. Heritable factors include PCOM, hyperandrogenemia, insulin resistance, and insulin secretory defects. Environmental factors include prenatal androgen exposure and poor fetal growth, whereas acquired obesity is a major postnatal factor. The variety of pathways involved and lack of a common thread attests to the multifactorial nature and heterogeneity of the syndrome. Further research into the fundamental basis of the disorder will be necessary to optimally correct androgen levels, ovulation, and metabolic homeostasis.

Project description:BackgroundHyperandrogenism (HA) has been linked with several components of metabolic syndrome (MetS). Few studies in Asian women have evaluated the important risk factors for and prevalence of MetS according to PCOS subtype. In this study, we investigated differences in metabolic parameters and the prevalence of MetS in two major phenotypic subgroups of PCOS in Korea. Furthermore, we investigated the relationship between HA-associated parameters and MetS.Materials and methodsThis cross-sectional observational study was conducted from May 2010 to December 2011 in Korea. A total of 837 females with PCOS, aged 15-40, were recruited from Departments of Obstetrics and Gynecology at 13 hospitals. Of those, 700 subjects with either polycystic ovaries (PCO)+HA+oligomenorrhea/amenorrhea (O) or PCO+O were eligible for this study. MetS was diagnosed according to the modified National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines and the International Diabetes Federation (IDF) criteria.ResultsMetS was more prevalent in the PCO+HA+O group (19.7%) than in the PCO+O (11.9%) group. There were statistically significant trends for an increased risk of MetS in the PCO+HA+O group compared to the PCO+O group. After adjustment for age, the odds ratio of MetS was 2.192 in non-obese subjects with PCO+HA+O compared to those with PCO+O, whereas the risk of MetS was not different in obese patients. Multivariate logistic regression analysis showed that high free androgen index and low sex hormone-binding globulin were significantly associated with MetS in non-obese women with PCOS, with odds ratios of 4.234 (95% CI, 1.893-9.474) and 4.612 (95% CI, 1.978-10.750), respectively. However, no associations were detected between MetS and SHBG and FAI in obese PCOS subjects.ConclusionsOur results indicate that HA and its associated parameters (FAI and SHBG) are significantly associated with MetS in non-obese PCOS subjects, whereas this association was not observed in obese subjects.

Project description:BackgroundPolycystic ovary syndrome (PCOS) affects 8% to 13% of reproductive-aged women and is associated with reproductive and metabolic dysfunction. Obesity worsens the presentation of PCOS and weight management (weight loss, maintenance or prevention of excess weight gain) is proposed as an initial treatment strategy, best achieved through lifestyle changes incorporating diet, exercise and behavioural interventions.ObjectivesTo assess the effectiveness of lifestyle treatment in improving reproductive, anthropometric (weight and body composition), metabolic and quality of life factors in PCOS.Search methodsWe searched the Cochrane Gynaecology and Fertility Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL and AMED (date of last search March 2018). We also searched controlled trials registries, conference abstracts, relevant journals, reference lists of relevant papers and reviews, and grey literature databases, with no language restrictions applied.Selection criteriaRandomised controlled trials (RCTs) comparing lifestyle treatment (diet, exercise, behavioural or combined treatments) to minimal or no treatment in women with PCOS.Data collection and analysisTwo authors independently selected trials, assessed evidence quality and risk of bias, and extracted data. Our primary outcomes were live birth, miscarriage and pregnancy. We used inverse variance and fixed-effect models in the meta-analyses. We reported dichotomous outcomes as an odds ratio and continuous outcomes as a mean difference (MD) or standardised mean difference (SMD).Main resultsWe included 15 studies with 498 participants. Ten studies compared physical activity to minimal dietary and behavioural intervention or no intervention. Five studies compared combined dietary, exercise and behavioural intervention to minimal intervention. One study compared behavioural intervention to minimal intervention. Risk of bias varied: eight studies had adequate sequence generation, seven had adequate clinician or outcome assessor blinding, seven had adequate allocation concealment, six had complete outcome data and six were free of selective reporting. No studies assessed the fertility primary outcomes of live birth or miscarriage. No studies reported the secondary reproductive outcome of menstrual regularity, as defined in this review.Lifestyle intervention may improve a secondary (endocrine) reproductive outcome, the free androgen index (FAI) (MD -1.11, 95% confidence interval (CI) -1.96 to -0.26, 6 RCTs, N = 204, I2 = 71%, low-quality evidence). Lifestyle intervention may reduce weight (kg) (MD -1.68 kg, 95% CI -2.66 to -0.70, 9 RCTs, N = 353, I2 = 47%, low-quality evidence). Lifestyle intervention may reduce body mass index (BMI) (kg/m2) (-0.34 kg/m2, 95% CI -0.68 to -0.01, 12 RCTs, N = 434, I2= 0%, low-quality evidence). We are uncertain of the effect of lifestyle intervention on glucose tolerance (glucose outcomes in oral glucose tolerance test) (mmol/L/minute) (SMD -0.02, 95% CI -0.38 to 0.33, 3 RCTs, N = 121, I2 = 0%, low-quality evidence).Authors' conclusionsLifestyle intervention may improve the free androgen index (FAI), weight and BMI in women with PCOS. We are uncertain of the effect of lifestyle intervention on glucose tolerance. There were no studies that looked at the effect of lifestyle intervention on live birth, miscarriage or menstrual regularity. Most studies in this review were of low quality mainly due to high or unclear risk of bias across most domains and high heterogeneity for the FAI outcome.

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OR31-01 A Randomized Controlled Trial of a Lifestyle Intervention with Longitudinal Follow up on Ovarian Dysmorphology, Hyperandrogenism, and Menstrual Irregularity in Women with Polycystic Ovary Syndrome

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