Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): a two-arm randomised feasibility protocol trial of an intermittent low-energy diet (ILED) in women with gestational diabetes and obesity in Greater Manchester.

INTRODUCTION: The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence guidance advises first-line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention among women with GDM compared with best National Health Service (NHS) care. METHOD AND ANALYSIS: We aim to recruit 48 women with GDM diagnosed between 24 and 30 weeks gestation from antenatal clinics at Wythenshawe and St Mary's hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000 kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial and adherence to both dietary interventions. Safety outcomes will include birth weight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0 mmol/L). Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals' experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Cambridge East Research Ethics Committee (22/EE/0119). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and shared with diabetes charitable bodies and organisations in the UK, such as Diabetes UK and the Association of British Clinical Diabetologists. TRIAL REGISTRATION NUMBER: NCT05344066.

Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1): protocol for a randomised feasibility trial of an intermittent and continuous low-energy diet in patients with type 1 diabetes and overweight and obesity.

INTRODUCTION: Rising levels of overweight and obesity among people with type 1 diabetes (T1D) contribute to insulin resistance, dyslipidaemia, retinopathy, cardiometabolic complications and psychological morbidity. Continuous low-energy diets (CLED) providing approximately 800 kcal (3347 kJ)/day can produce significant weight loss in type 2 diabetes, and intermittent low-energy diets (ILED) may be an alternative. The Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1) aims to assess the safety, acceptability and feasibility of remotely delivered ILED and CLED programmes for people with T1D and overweight and obesity. METHODS AND ANALYSIS: Twelve participants with T1D and body mass index ≥27.5 kg/m2 (≥25 kg/m2 in high-risk ethnic minorities) recruited from an National Health Service (NHS) trust and research register in England will be randomised to a remotely delivered CLED (n=6) or ILED (n=6) for 12 weeks. The CLED includes a daily Optifast 850 kcal (3556 kJ) 75 g carbohydrate formula diet. The ILED includes 2 days/week of Optifast and 5 days of a portion-controlled Mediterranean diet (170-250 g carbohydrate/day). Both groups will receive matched high-frequency remote support from a dietitian, nurse and psychologist via telephone and/or the Oviva app. The primary outcome will assess safety (occurrence of severe hypoglycaemia, ketonaemia, ketoacidosis and time above and below target blood glucose). Secondary outcomes include study uptake, retention, dietary adherence, acceptability, intervention delivery fidelity and potential efficacy in relation to change in weight, insulin requirements, glycated haemoglobin, lipids, insulin resistance (estimated glucose disposal rate) and quality of life. Participants will be invited for optional repeat measurements at 52 weeks. ETHICS AND DISSEMINATION: The trial protocol (V4.0/08.06.2022) was granted ethical approval by Cambridge East Research Ethics Committee (Ref: 21/EE/0014). The study will inform progression to a full-scale randomised controlled trial to test the efficacy of these programmes for patients with T1D and overweight and obesity. TRIAL REGISTRATION NUMBER: NCT04674384; Pre-results.

Adrenal Incidentaloma: Prevalence and Referral Patterns From Routine Practice in a Large UK University Teaching Hospital.

CONTEXT: Adrenal incidentalomas (AIs) are increasingly being identified during unrelated imaging. Unlike AI clinical management, data on referral patterns in routine practice are lacking. OBJECTIVE: This work aimed to identify factors associated with AI referral. METHODS: We linked data from imaging reports and outpatient bookings from a large UK teaching hospital. We examined (i) AI prevalence and (ii) pattern of referral to endocrinology, stratified by age, imaging modality, scan anatomical site, requesting clinical specialty, and temporal trends. Using key radiology phrases to identify scans reporting potential AI, we identified 4097 individuals from 479 945 scan reports (2015-2019). Main outcome measures included prevalence of AI and referral rates. RESULTS: Overall, AI lesions were identified in 1.2% of scans. They were more prevalent in abdomen computed tomography and magnetic resonance imaging scans (3.0% and 0.6%, respectively). Scans performed increased 7.7% year-on-year from 2015 to 2019, with a more pronounced increase in the number with AI lesions (14.7% per year).Only 394 of 4097 patients (9.6%) had a documented endocrinology referral code within 90 days, with medical (11.8%) more likely to refer than surgical (7.2%) specialties (P < .001). Despite prevalence increasing with age, older patients were less likely to be referred (P < .001). CONCLUSION: While overall AI prevalence appeared low, scan numbers are large and rising; the number with identified AI are increasing still further. The poor AI referral rates, even in centers such as ours where dedicated AI multidisciplinary team meetings and digital management systems are used, highlights the need for new streamlined, clinically effective systems and processes to appropriately manage the AI workload.

Manchester Intermittent versus Daily Diet App Study (MIDDAS): A pilot randomized controlled trial in patients with type 2 diabetes.

AIMS: To test the feasibility and potential efficacy of remotely supported intermittent low-energy diets (ILEDs) and continuous low-energy diets (CLEDs) in people with type 2 diabetes (T2D) and the feasibility of a randomized controlled trial comparing the two approaches. MATERIALS AND METHODS: Seventy-nine adults with overweight/obesity and T2D (≤8 years duration) were randomized 1:1 to CLED (8 weeks/56 days of daily Optifast 820 kcal (3430 kJ) diet) or isoenergetic ILED (2 days of Optifast and 5 days of a Mediterranean diet/week for 28 weeks). Weight maintenance/continued weight loss was undertaken for the remainder of the 52 weeks. Both groups received frequent telephone or the Oviva app support. Feasibility outcomes included study uptake, retention, app usage, dietary adherence, weight loss and change in glycated haemoglobin (HbA1c) at 52 weeks. RESULTS: We enrolled 39 ILED and 40 CLED participants and 27 (69%) ILED and 30 CLED (75%) attended the 52-week follow-up. Eighty-nine per cent (70 of 79) started using the app and 86% (44 of 51) still used the app at 52 weeks. Intention-to-treat analysis at 52 weeks showed percentage weight loss was mean (95% confidence interval) -5.4% (-7.6, -3.1%) for ILED and -6.0% (-7.9, -4.0%) for CLED. HbA1c <48 mmol/mol was achieved in 42% of both groups. Mean (95% confidence interval) changes in the T2D medication effect score were 0.0008 (-0.3, 0.3) for ILED and -0.5 (-0.8, -0.3) for CLED. CONCLUSION: The study shows the feasibility and potential efficacy of remotely delivered ILED and CLED programmes for weight loss and HbA1c reduction, and the feasibility of a randomized controlled trial comparing the two approaches.

Adrenal lesions found incidentally: how to improve clinical and cost-effectiveness.

INTRODUCTION: Adrenal incidentalomas are lesions that are incidentally identified while scanning for other conditions. While most are benign and hormonally non-functional, around 20% are malignant and/or hormonally active, requiring prompt intervention. Malignant lesions can be aggressive and life-threatening, while hormonally active tumours cause various endocrine disorders, with significant morbidity and mortality. Despite this, management of patients with adrenal incidentalomas is variable, with no robust evidence base. This project aimed to establish more effective and timely management of these patients. METHODS: We developed a web-based, electronic Adrenal Incidentaloma Management System (eAIMS), which incorporated the evidence-based and National Health Service-aligned 2016 European guidelines. The system captures key clinical, biochemical and radiological information necessary for adrenal incidentaloma patient management and generates a pre-populated outcome letter, saving clinical and administrative time while ensuring timely management plans with enhanced safety. Furthermore, we developed a prioritisation strategy, with members of the multidisciplinary team, which prioritised high-risk individuals for detailed discussion and management. Patient focus groups informed process-mapping and multidisciplinary team process re-design and patient information leaflet development. The project was partnered by University Hospital of South Manchester to maximise generalisability. RESULTS: Implementation of eAIMS, along with improvements in the prioritisation strategy, resulted in a 49% reduction in staff hands-on time, as well as a 78% reduction in the time from adrenal incidentaloma identification to multidisciplinary team decision. A health economic analysis identified a 28% reduction in costs. CONCLUSIONS: The system's in-built data validation and the automatic generation of the multidisciplinary team outcome letter improved patient safety through a reduction in transcription errors. We are currently developing the next stage of the programme to proactively identify all new adrenal incidentaloma cases.