Rationale and design of a randomised controlled trial testing the effect of personalised diet in individuals with pre-diabetes or type 2 diabetes mellitus treated with metformin.

INTRODUCTION: Metformin and diets aimed at promoting healthy body weight are the first line in treating type 2 diabetes mellitus (T2DM). Clinical practice, backed by clinical trials, suggests that many individuals do not reach glycaemic targets using this approach alone. The primary aim of the Personalised Medicine in Pre-diabetes-Towards Preventing Diabetes in Individuals at Risk (PREDICT) Study is to test the efficacy of personalised diet as adjuvant to metformin in improving glycaemic control in individuals with dysglycaemia. METHODS AND ANALYSIS: PREDICT is a two-arm, parallel group, single-masked randomised controlled trial in adults with pre-diabetes or early-stage T2DM (with glycated haemoglobin (HbA1c) up to 8.0% (64 mmol/mol)), not treated with glucose-lowering medication. PREDICT is conducted at the Clinical Research Facility at the Garvan Institute of Medical Research (Sydney). Enrolment of participants commenced in December 2018 and expected to complete in December 2021. Participants are commenced on metformin (Extended Release, titrated to a target dose of 1500 mg/day) and randomised with equal allocation to either (1) the Personalised Nutrition Project algorithm-based diet or (2) low-fat high-dietary fibre diet, designed to provide caloric restriction (75%) in individuals with body mass index >25 kg/m2. Treatment duration is 6 months and participants visit the Clinical Research Facility five times over approximately 7 months. The primary outcome measure is HbA1c. The secondary outcomes are (1) time of interstitial glucose <7.8 mmol/L and (2) glycaemic variability (continuous glucose monitoring), (3) body weight, (4) fat mass and (5) abdominal visceral fat volume (dual-energy X-ray absorptiometry), serum (6) low-density lipoprotein cholesterol (7) high-density lipoprotein cholesterol and (8) triglycerides concentrations, (9) blood pressure, and (10) liver fat (Fibroscan). ETHICS AND DISSEMINATION: The study has been approved by the St Vincent's Hospital Human Research Ethics Committee (File 17/080, Sydney, Australia) and the Weizmann Institutional Review Board (File 528-3, Rehovot, Israel). The findings will be published in peer-reviewed open access medical journals. TRIAL REGISTRATION NUMBER: NCT03558867; Pre-results.

Informing Translation: The Accuracy of Information on Websites for Lifestyle Management of Polycystic Ovary Syndrome.

Lifestyle (diet, physical activity [PA], and/or behavioral) interventions are recommended for all women with polycystic ovary syndrome (PCOS) in international guidelines. The internet is a widely used health information resource. However, the accuracy of lifestyle information on PCOS websites is unknown and is reviewed here to inform translation of the international guideline on PCOS. An internet search was conducted with three search engines across different web browsers and countries. Accuracy was assessed through a checklist of 29 questions based on international guidelines for diet, PA, or weight management for the general population and for PCOS with higher scores indicating greater accuracy. Fifteen websites were eligible out of 72 (20%). The total accuracy score was 56 ± 13 (mean ± standard deviation; potential range: -29 to 87) comprising 23 ± 6 for diet (-11 to 33), 15 ± 5 for PA (-9 to 27), and 14 ± 3 for weight management (-8 to 24). A moderate proportion of websites provided general information on appropriate diet (40-80%) or weight management strategies (47-60%), but only 10 to 40% of websites provided information on core foods, discretionary foods, exercise quantity/intensity, energy deficits, or behavioral strategies. Limited websites on PCOS contain information on lifestyle management. The majority provided information on general diet, PA, and weight recommendations but less information on practical implementation of lifestyle change as an identified translation gap for the international guideline on PCOS.

Asthma in reproductive-aged women with polycystic ovary syndrome and association with obesity.

Recent research suggests that women with polycystic ovary syndrome (PCOS) may have a higher prevalence of asthma. However, there are no epidemiological studies aimed primarily at exploring the relationship between PCOS and asthma, and the effect of body mass index (BMI) on this association.This study is a cross-sectional analyses of data from the Australian Longitudinal Study on Women's Health, a large, community-based, prospective study to examine the association between PCOS and asthma in women aged 28-33 years (n=478 PCOS and n=8134 controls).The prevalence of asthma was 15.2% in women with PCOS and 10.6% in women without PCOS (p=0.004). Women with PCOS who had asthma had a trend for a higher BMI compared with women without asthma (29.9±0.9 versus 27.7±0.4 kg·m-2; p=0.054). Women without PCOS who had asthma had a higher BMI compared with women without asthma (26.4±0.2 versus 24.9±0.1 kg·m-2; p<0.001). After adjusting for age, BMI and smoking status, PCOS was associated with increased odds of asthma (odds ratio 1.34, 95% CI 1.004-1.79; p=0.047).This study showed both PCOS status and overweight/obese status were independently associated with asthma. Further prospective studies are required to explore the possible mechanisms underpinning the association between asthma and PCOS.