Recent Submissions

  • Baby Steps - a structured group education programme with accompanying mobile web application designed to promote physical activity in women with a history of gestational diabetes : study protocol for a randomised controlled trial

    Sukumar, Nithya; Dallosso, Helen; Saravanan, Ponnusamy; Yates, Tom; Telling, Carol; Shorthose, Karen; Northern, Alison; Schreder, Sally; Brough, Christopher; Gray, Laura J.; et al. (BioMed Central, 2018-12-12)
    Background: A diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Lifestyle interventions have been shown to reduce the risk of incident T2D in adults with impaired glucose tolerance, including in women with a history of GDM. The aim of this study is to establish whether a group self-management education programme, supported by a mobile web application, can improve levels of physical activity at 12 months in women who have had GDM. Methods: The study is a randomised controlled trial with follow-up at 6 and 12 months. Primary outcome is change in objectively measured average daily physical activity at 12 months. Secondary outcomes include lipid profile, blood pressure, glycated haemoglobin, obesity, smoking and alcohol status, self-reported physical activity, anxiety, depression and quality of life. Participants are recruited from maternity and diabetes departments in hospital trusts in two sites in the UK. Women aged > 18 years, with a diagnosis of GDM during any pregnancy in the previous 60 months are eligible. Participants need to have a good understanding of written and verbal English, be able to give informed consent and have access to a smart-phone. Women who are pregnant or have type 1 or type 2 diabetes are not eligible. In total, 290 participants will be recruited and randomly assigned, with stratification for age and ethnicity, to either the control group, receiving usual care, or the intervention group who are invited to participate in the Baby Steps programme. This comprises a group education programme and access to a mobile web application which provides an education component and interacts with a wrist-worn activity monitor providing automated messages, setting challenges and encouraging motivation. Discussion: If effective, the Baby Steps programme could be translated into a primary care-based intervention that women with GDM are referred to in the postnatal period. This could help them make lifestyle changes that could reduce their future risk of T2D. Trial registration: ISRCTN, ISRCTN17299860 . Registered on 5 April 2017.
  • The use of ezetimibe in achieving low density lipoprotein lowering goals in clinical practice: position statement of a United Kingdom consensus panel

    Mikhailidis, D. P.; Wierzbicki, A. S.; Daskalopoulou, S. S.; Al-Saady, N; Griffiths, H; Hamilton, G; Monkman, D; Patel, V; Pittard, J; Schachter, M; et al. (Informa Healthcare, 2005-06)
    There is no doubt that lowering serum cholesterol levels reduces the risk of major coronary events. This evidence has led treatment guidelines to set progressively lower targets for low density lipoprotein cholesterol (LDL-C). However, despite widespread use of statins, substantial numbers of patients do not achieve the LDL-C goals. Using higher doses of statins in an attempt to achieve these targets may increase the risk of serious adverse effects. Furthermore, the use of combination therapy with agents such as bile acid sequestrants, niacin and fibrates has been limited by increased potential for side effects, drug interactions and poor compliance. Ezetimibe, a selective cholesterol transport inhibitor, reduces the intestinal uptake of cholesterol without affecting absorption of triglycerides or fat-soluble vitamins. In clinical studies, ezetimibe 10 mg, in combination with statins or as monotherapy, was well tolerated and reduced LDL-C by 34-53% and 17-18%, respectively. The available evidence for ezetimibe is reviewed. The role of ezetimibe in increasing the proportion of patients attaining LDL-C treatment goals is discussed.
  • Efficacy and Safety of Rapid-Acting Insulin Analogs in Special Populations with Type 1 Diabetes or Gestational Diabetes : Systematic Review and Meta-Analysis

    Nørgaard, Kirsten; Sukumar, Nithya; Rafnsson, Snorri B.; Saravanan, Ponnusamy; Saravanan, Ponnusamy; Diabetes, Endocrinology and Metabolism; Medical and Dental; Copenhagen University Hospital Hvidovre, Denmark; Steno Diabetes Center Copenhagen, Denmark; University of Warwick; London Metropolitan University; University College London; George Eliot Hospital (Springer, 2018)
    Introduction: To assess the efficacy and safety of three available rapid-acting insulin analogs (insulins lispro, aspart and glulisine, respectively) in pregnant women, children/adolescents and people using continuous subcutaneous insulin infusion (CSII) with type 1 diabetes. Methods: PubMed, EMBASE and Cochrane Reviews were searched electronically, and their bibliographies examined to identify suitable studies for review and inclusion in a meta-analysis. Eligible studies were randomized controlled trials that reported data on relevant clinical outcomes. A different reviewer abstracted data for each of the three subpopulations, and one reviewer abstracted data for all three. Any differences were resolved by consensus or by consulting a fourth reviewer. Results: In people on CSII, rapid-acting insulin analogs lowered postprandial plasma glucose post-breakfast to a greater extent than did regular human insulin (RHI) (mean difference: - 1.63 mmol/L [95% confidence interval - 1.71; - 1.54]), with a comparable risk of hypoglycemia and a trend for lower glycated hemoglobin. In the pediatric population, glycemic control was similar with rapid-acting insulin analogs and RHI, with no safety concerns. Meta-analysis indicated severe hypoglycemic events were comparable for rapid-acting insulin analogs versus RHI (risk difference: 0.00 [95% confidence interval - 0.01; 0.01]). In the pregnancy group, insulin lispro and insulin aspart were safe and effective for both mother and fetus, with glycemic control being at least as good as with RHI. There were no data on insulin glulisine during pregnancy. Conclusion: Rapid-acting insulin analogs appear generally safe and effective in these special populations; however, additional trials would be helpful. Funding: Novo Nordisk A/S.
  • Lipid management in Type 1 diabetes

    Pachaiappan, K J.; Patel, V; Morrissey, J; Gadsby, R; Morrissey, J.; Red Roofs Surgery; University of Warwick; George Eliot Hospital (Wiley, 2006-03)
    No abstract available
  • Machine learning prediction of non-attendance to postpartum glucose screening and subsequent risk of type 2 diabetes following gestational diabetes

    Periyathambi, Nishanthi; Parkhi, Durga; Ghebremichael-Weldeselassie, Yonas; Patel, Vinod; Sukumar, Nithya; Siddharthan, Rahul; Narlikar, Leelavati; Saravanan, Ponnusamy; Periyathambi, Nishanthi; Patel, Vinod; et al. (Public Library of Science, 2022-03-07)
    Objective: The aim of the present study was to identify the factors associated with non-attendance of immediate postpartum glucose test using a machine learning algorithm following gestational diabetes mellitus (GDM) pregnancy. Method: A retrospective cohort study of all GDM women (n = 607) for postpartum glucose test due between January 2016 and December 2019 at the George Eliot Hospital NHS Trust, UK. Results: Sixty-five percent of women attended postpartum glucose test. Type 2 diabetes was diagnosed in 2.8% and 21.6% had persistent dysglycaemia at 6-13 weeks post-delivery. Those who did not attend postpartum glucose test seem to be younger, multiparous, obese, and continued to smoke during pregnancy. They also had higher fasting glucose at antenatal oral glucose tolerance test. Our machine learning algorithm predicted postpartum glucose non-attendance with an area under the receiver operating characteristic curve of 0.72. The model could achieve a sensitivity of 70% with 66% specificity at a risk score threshold of 0.46. A total of 233 (38.4%) women attended subsequent glucose test at least once within the first two years of delivery and 24% had dysglycaemia. Compared to women who attended postpartum glucose test, those who did not attend had higher conversion rate to type 2 diabetes (2.5% vs 11.4%; p = 0.005). Conclusion: Postpartum screening following GDM is still poor. Women who did not attend postpartum screening appear to have higher metabolic risk and higher conversion to type 2 diabetes by two years post-delivery. Machine learning model can predict women who are unlikely to attend postpartum glucose test using simple antenatal factors. Enhanced, personalised education of these women may improve postpartum glucose screening.
  • Optimising the Benefits of SGLT2 Inhibitors for Type 1 Diabetes

    Evans, Marc; Hicks, Debbie; Patel, Dipesh; McEwan, Phil; Dashora, Umesh; Patel, Vinod; Patel, Vinod; Diabetes and Endocrinology; Medical and Dental; University Hospital Llandough; Medicus Health Partners; Royal Free NHS Trust; University of Warwick; George Eliot Hospital NHS Trust; Health Economics and Outcomes Research Ltd; East Sussex Healthcare NHS Trust (Springer, 2019-12-07)
    Sodium-glucose cotransporter 2 (SGLT2) inhibitor clinical studies in type 1 diabetes mellitus (T1DM) have demonstrated reduced HbA1c and lower glucose variability with increased time in optimal glucose range as well as additional benefits of reductions in weight and insulin dose without increasing the incidence of hypoglycaemia. However, the appropriate use of SGLT2 inhibitor therapies within clinical practise to treat people with T1DM remains unclear. In this article we have used consensus expert opinion alongside the available evidence, product indication and most recent clinical guidance to provide support for the diabetes healthcare community regarding the appropriate use of SGLT2 inhibitors, focussing on specific considerations for appropriate prescribing of dapagliflozin within the T1DM management pathway. Its purpose is to provide awareness of the issues surrounding treatment with dapagliflozin in T1DM as well as offer practical guidance that also includes a checklist tool for appropriate dapagliflozin prescribing. The checklist aims to support clinicians in identifying those people with T1DM most likely to benefit from dapagliflozin treatment as well as situations where caution may be required.Funding: AstraZeneca UK Ltd.
  • Perioperative Pain Management in Patients Undergoing Total Hip Arthroplasty: Where Do We Currently Stand?

    Tsinaslanidis, Georgios; Tsinaslanidis, Prodromos; Mahajan, Ravindra H.; Tsinaslanidis, Georgios; Mahajan, Ravindra H.; Trauma and Orthopaedics; Medical and Dental; George Eliot Hospital NHS Trust: St. George's University Hospitals NHS Foundation Trust. (Springer, 2020-07-07)
    Total Hip replacement (THR) is a well-discussed topic, and it offers excellent results in patients suffering from end-stage osteoarthritis (OA). However, despite the fact that patients can fully bear weight immediately after the surgery, THR is often associated with a great amount of postoperative pain affecting recovery and rehabilitation. Therefore, the efficient management of pain is of paramount importance. The aim of this review is to examine all the currently available strategies of pain management such as preemptive analgesia (PA), patient-controlled analgesia (PCA), and the various types of anesthesia that are used during the operation. With that objective in mind, we conducted our research by searching through the PubMed database for articles published in 2015 and after. For purely clinical reasons, we have attempted to classify all the best available evidence into three major categories: prior to surgery, during the surgery, and after the surgery. Multimodal analgesia seems to play a major role in the perioperative care of patients undergoing total hip arthroplasty (THA). Therefore, a considerable number of studies have been conducted analyzing all the current strategies that aim to minimize perioperative pain and consequent complications.
  • ENDOCRINOLOGY IN THE TIME OF COVID-19: Diagnosis and management of gestational diabetes mellitus

    Thangaratinam, Shakila; Cooray, Shamil D; Sukumar, Nithya; Huda, Mohammed S B; Devlieger, Roland; Benhalima, Katrien; McAuliffe, Fionnuala; Saravanan, Ponnusamy; Teede, Helena J; Saravanan, Ponnusamy; et al. (BioScientifica, 2020-08-01)
    The COVID-19 pandemic has required rapid transformation and adaptation of healthcare services. Women with gestational diabetes mellitus (GDM) are one of the largest high-risk groups accessing antenatal care. In reformulating the care offered to those with GDM, there is a need to balance the sometimes competing requirement of lowering the risk of direct viral transmission against the potential adverse impact of service changes. We suggest pragmatic options for screening of GDM in a pandemic setting based on blood tests, and risk calculators applied to underlying risk factors. Alternative models for antenatal care provision for women with GDM, including targeting high-risk groups, early lifestyle interventions and remote monitoring are provided. Testing options and their timing for postpartum screening in women who had GDM are also considered. Our suggestions are only applicable in a pandemic scenario, and usual guidelines and care pathways should be re-implemented as soon as possible and appropriate.
  • Vitamin B12 deficiency and altered one-carbon metabolites in early pregnancy is associated with maternal obesity and dyslipidaemia

    Adaikalakoteswari, Antonysunil; Wood, Catherine; Mina, Theresia H.; Webster, Craig; Goljan, Ilona; Weldeselassie, Yonas; Reynolds, Rebecca M.; Saravanan, Ponnusamy; Wood, Catherine; Goljan, Ilona; et al. (Nature Research, 2020-07-06)
    Vitamin B12 (B12) is a micronutrient essential for one-carbon (1C) metabolism. B12 deficiency disturbs the 1C cycle and alters DNA methylation which is vital for most metabolic processes. Studies show that B12 deficiency may be associated with obesity, insulin resistance and gestational diabetes; and with obesity in child-bearing women. We therefore hypothesised that the associations between B12 deficiency, BMI and the metabolic risk could be mediated through altered 1C metabolites in early pregnancy. We explored these associations in two different early pregnancy cohorts in the UK (cohort 1; n = 244 and cohort 2; n = 60) with anthropometric data at 10-12 weeks and plasma/serum sampling at 16-18 weeks. B12, folate, total homocysteine (tHcy), methionine, MMA, metabolites of 1C metabolism (SAM, SAH) and anthropometry were measured. B12 deficiency (< 150 pmol/l) in early pregnancy was 23% in cohort 1 and 18% in cohort 2. Regression analysis after adjusting for likely confounders showed that B12 was independently and negatively associated with BMI (Cohort 1: β = - 0.260, 95% CI (- 0.440, - 0.079), p = 0.005, Cohort 2: (β = - 0.220, 95% CI (- 0.424, - 0.016), p = 0.036) and positively with HDL cholesterol (HDL-C) (β = 0.442, 95% CI (0.011,0.873), p = 0.045). We found that methionine (β = - 0.656, 95% CI (- 0.900, - 0.412), p < 0.0001) and SAH (β = 0.371, 95% CI (0.071, 0.672), p = 0.017) were independently associated with triglycerides. Low B12 status and alteration in metabolites in 1C metabolism are common in UK women in early pregnancy and are independently associated with maternal obesity and dyslipidaemia. Therefore, we suggest B12 monitoring in women during peri-conceptional period and future studies on the pathophysiological relationship between changes in 1C metabolites and its association with maternal and fetal outcomes on larger cohorts. This in turn may offer potential to reduce the metabolic risk in pregnant women and their offspring.
  • A ten-year observational study of the use of two-way catheters post-transurethral resection of the prostate without the use of post-op irrigation

    Kretzmer, Leo; Damola, Adebiyi; Apakama, Ike; Sandher, Manvir JS; Martin, William; Ehsanullah, Syed Ali; Jones, Adam; Cakir, Serkan; Gao, Jo; Ginepri, Andrea; et al. (SAGE Publications, 2022-04-01)
    Background: Over 15,000 transurethral resections of the prostate (TURP) are performed annually in the United Kingdom. It is therefore vital that every aspect of peri-operative care be optimised. Our centre favours the use of two-way catheters post-operatively without the use of continuous bladder irrigation (CBI). Objectives: To evaluate our practice of using two-way catheters without irrigation post-TURP and to determine impact on patient care compared with standard three-way catheterisation. Our primary outcome was duration of admission, but multiple secondary outcomes were also analysed. Design, setting, and participants: This was a prospective observational study. Every patient undergoing TURP at our centre from 2009 to 2019 was included. Following TURP patients were catheterised with two-way catheters. Prospective patient data were collected pertaining to peri-operative factors. These data were then compared with the data published in the literature. Results: 687 patients underwent TURP at our centre between 2009 and 2019. The average age of patients was 71.42 (±7.89). 87.17% (n = 598) had two-way catheters placed post-operatively. Average duration of admission was 1.61 (±1.35) days, increasing to 2.20 days if patients required three-way catheters or 2.53 days if requiring CBI. TWOC was successful in 97.71% of patients. Complication rate was 8.73% (n = 60). When compared with other centres, our method reduced lengths of admission and transfusion rates (1.6 days versus 3.1 days and 0.87% versus 2.83%, respectively). Conclusion: Our method is safe and is associated with a reduced length of admission. We recommend this practice to the wider urological community. Patient summary: This study looked at whether there was any impact on patients if two-way catheters were used following TURP. We found that use of two-way catheters reduced length of admission and duration of catheterisation. We also found that it did not increase likelihood of peri-operative complications in comparison with other centres.
  • Prevalence of prediabetes and type 2 diabetes mellitus in south and southeast Asian women with history of gestational diabetes mellitus: Systematic review and meta-analysis

    Shivashri, Chockalingam; Deepa, Mohan; Ghebremichael-Weldeselassie, Yonas; Mohan Anjana, Ranjit; Uma, Ram; Mohan, Viswanathan; Saravanan, Ponnusamy; Saravanan, Ponnusamy; Department of Diabetes, Endocrinology, and Metabolism, George Eliot Hospital, Nuneaton, United Kingdom.; Medical and Dental; et al. (Public Library of Science, 2022-12-12)
    Background: The burden of Gestational Diabetes Mellitus (GDM) is very high in south Asia (SA) and southeast Asia (SEA). Thus, there is a need to understand the prevalence and risk factors for developing prediabetes and type 2 diabetes mellitus (T2DM) postpartum, in this high-risk population. Aim: To conduct a systematic review and meta-analysis to estimate the prevalence of prediabetes and T2DM among the women with history of GDM in SA and SEA. Methods: A comprehensive literature search was performed in the following databases: Medline, EMBASE, Web of Knowledge and CINHAL till December 2021. Studies that had reported greater than six weeks of postpartum follow-up were included. The pooled prevalence of diabetes and prediabetes were estimated by random effects meta-analysis model and I2 statistic was used to assess heterogeneity. Results: Meta-analysis of 13 studies revealed that the prevalence of prediabetes and T2DM in post-GDM women were 25.9% (95%CI 18.94 to 33.51) and 29.9% (95%CI 17.02 to 44.57) respectively. Women with history of GDM from SA and SEA seem to have higher risk of developing T2DM than women without GDM (RR 13.2, 95%CI 9.52 to 18.29, p<0.001). The subgroup analysis showed a rise in the prevalence of T2DM with increasing duration of follow-up. Conclusion: The conversion to T2DM and prediabetes is very high among women with history of GDM in SA and SEA. This highlights the need for follow-up of GDM women for early identification of dysglycemia and to plan interventions to prevent/delay the progression to T2DM.
  • Informing and Empowering Patients and Clinicians to Make Evidence-Supported Outcome-Based Decisions in Relation to SGLT2 Inhibitor Therapies: The Use of the Novel Years of Drug administration (YoDa) Concept

    Varadhan, Lakshminarayanan; Saravanan, Ponnusamy; Ali, Sarah N; Hanif, Wasim; Hanif, Wasim; Patel, Vinod; Patel, Vinod; Saravanan, Ponnusamy; Department of Diabetes, Endocrinology and Metabolism; Medical and Dental; et al. (Adis, 2022-02-02)
    The American Diabetes Association guidelines for the management of type 2 diabetes mellitus recommends treating patients with atherosclerotic cardiovascular diseases, heart failure or diabetic kidney disease with sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists, irrespective of the baseline HbA1c, to reduce adverse renal and cardiovascular outcomes. Initiation of such therapies have a significant cost impact on health economies. Cost of gain in quality-adjusted life-years is normally used for cost effectiveness for a particular drug. In the absence of head-to-head comparisons, prescribers may go for the cheapest option, which may not necessarily be the right decision. We propose using the calculated 'YoDa' (Years of Drug administration) as an easily comparable metric between the drug accrual cost and clinical outcomes. YoDa is calculated as a product of numbers needed to treat and the median duration in years that the trial ran over, to accrue the positive clinical outcomes. Clinical phenotyping of the patient to the specific inclusion and exclusion criteria of relevant clinical trials could guide the clinician to choose the most appropriate therapy. We also propose a series of steps or 'deliberations', which a clinician should consider in making a final choice of sodium-glucose co-transporter-2 inhibitor therapy. A comprehensive summary of the sodium-glucose co-transporter-2 inhibitor trials, clinical phenotyping and YoDa calculations for various significant clinical outcomes could assist making evidence-based, patient-individualised and cost-effective management plans for diabetes care. Informing and Empowering Patients and Clinicians to Make Evidence-Supported Outcome-Based Decisions in Relation to SGLT2 Inhibitor Therapies: The Use of The Novel Years of Drug administration (YoDa) Concept.
  • Use of percutaneous cholecystostomy for complicated acute lithiasic cholecystitis: solving or deferring the problem?

    Malik, Adnan; Seretis, Charalampos; Malik, Adnan; General Surgery; Medical and Dental; George Eliot Hospital NHS Trust; General University Hospital of Patras (Fundacja Polski Przegląd Chirurgiczny, 2021-10-20)
    Introduction: Percutaneous cholecystostomies are not infrequently used as an adjunct in the treatment of severe lithiasic cholecystitis, particularly in unstable and comorbid patients. However, their out of proportion liberal use tends to substitute the performance of emergency cholecystectomy, which the definitive treatment. Aim: Our aim was to assess the short and long-term outcomes of patients who had percutaneous cholecystostomy insertion due to severe lithiasic cholecystitis, aiming to define areas for improvement of our institutional practice. Materials and Methods: Retrospective review of our institutional practice including all patients who had a percutaneous cholecystostomy for complex lithiasic cholecystitis, over a 5-year period, allowing for an additional 1-year follow up. Results: A total of 34 patients were included in our final analysis. Percutaneous cholecystostomy insertion enabled quick and efficient control of the source of biliary sepsis without major procedural complications in all cases. In 14 (41.2%) patients, cholecystostomy alone served as definitive treatment, while in 20 (58.9%) cases it was used as bridging strategy for delayed elective cholecystectomy. In the delayed cholecystectomy group of patients, we noted a high conversion rate from laparoscopic to open surgery rate of 70%, with an overall subtotal cholecystectomy rate of 60%. Conclusion: Percutaneous cholecystostomies should be reserved only for complex lithiasic cholecystitis patients who are unwilling and/or unfit for surgery. We advocate the performance of upfront emergency cholecystectomy in any other case with liberal use of operative bail-out strategies, as a delayed elective operation is anyway likely to be converted to open and/or subtotal cholecystectomy.
  • Prevention of Microvascular Complications of Diabetes

    Crasto, Winston; Patel, Vinod; Davies, Melanie; Khunti, Kamlesh; Crasto, Winston; Patel, Vinod; Davies, Melanie; Khunti, Kamlesh; Diabetes and Endocrinology; Medical and Dental; et al. (Elsevier, 2021-08-13)
    Microvascular complications of diabetes present a significant challenge due to their diverse presentations, significant morbidity, and as strong predictors of cardiovascular disease. Prevention and management strategies should focus on lifestyle modification, education and awareness, systematic screening for early complications, and intensive management of modifiable risk factors. This review discusses the microvascular complications of diabetes, including diabetic retinopathy, diabetic kidney disease, and diabetic neuropathy, and provides best practice clinical care recommendations to guide health care professionals to better manage people with these conditions.