Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial(BioMed Central, London, 2021) Kasturiratne, A.; Khawaja, K.I.; Ahmad, S.; Siddiqui, S.; Shahzad, K.; Athauda, L.K.; Jayawardena, R.; Mahmood, S.; Muilwijk, M.; Batool, T.; Burney, S.; Glover, M.; Palaniswamy, S.; Bamunuarachchi, V.; Panda, M.; Madawanarachchi, S.; Rai, B.; Sattar, I.; Silva, W.; Waghdhare, S.; Jarvelin, M.R.; Rannan-Eliya, R.P.; Gage, H.M.; van Valkengoed, I.G.M.; Valabhji, J.; Frost, G.S.; Loh, M.; Wickremasinghe, A.R.; Kooner, J.S.; Katulanda, P.; Jha, S.; Chambers, J.C.Background: People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings.Hypothesis: Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers.Design: Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years.Entry criteria: South Asian, men or women, age 40-70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0-6.4% inclusive).Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness.Endpoints: The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. Intervention: Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. Results: We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). Conclusion: The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group.Item Effects of a lifestyle intervention programme after 1 year of follow-up among South Asians at high risk of type 2 diabetes: a cluster randomised controlled trial(BMJ Publishing Group Ltd, 2021) Muilwijk, M.; Loh, M.; Siddiqui, S.; Mahmood, S.; Palaniswamy, S.; Shahzad, K.; Athauda, L.K.; Jayawardena, R.; Batool, T.; Burney, S.; Glover, M.; Bamunuarachchi, V.; Panda, M.; Madawanarachchi, M.; Rai, B.; Sattar, I.; Silva, W.; Waghdhare, S.; Jarvelin, M.R.; Rannan-Eliya, R.P.; Wijemunige, N.; Gage, H.M.; Valabhji, J.; Frost, G.S.; Wickremasinghe, R.; Kasturiratne, A.; Khawaja, K.I.; Ahmad, S.; Valkengoed, I.G.V.; Katulanda, P.; Jha, S.; Kooner, J.S.; Chambers, J.C.Introduction South Asians are at high risk of type 2 diabetes (T2D). We assessed whether intensive family-based lifestyle intervention leads to significant weight loss, improved glycaemia and blood pressure in adults at elevated risk for T2D.Methods This cluster randomised controlled trial (iHealth-T2D) was conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. We included 3684 South Asian men and women, aged 40–70 years, without T2D but with raised haemoglobin A1c (HbA1c) and/or waist circumference. Participants were randomly allocated either to the family-based lifestyle intervention or control group by location clusters. Participants in the intervention received 9 visits and 13 telephone contacts by community health workers over 1-year period, and the control group received usual care. Reductions in weight (aim >7% reduction), waist circumference (aim ≥5 cm reduction), blood pressure and HbA1C at 12 months of follow-up were assessed. Our linear mixed-effects regression analysis was based on intention-to-treat principle and adjusted for age, sex and baseline values. Results There were 1846 participants in the control and 1838 in the intervention group. Between baseline and 12 months, mean weight of participants in the intervention group reduced by 1.8 kg compared with 0.4 kg in the control group (adjusted mean difference −1.10 kg (95% CI −1.70 to −1.06), p<0.001). The adjusted mean difference for waist circumference was −1.9 cm (95% CI −2.5; to 1.3), p<0.001). No overall difference was observed for blood pressure or HbA1c. People who attended multiple intervention sessions had a dose-dependent effect on waist circumference, blood pressure and HbA1c, but not on weight. Conclusion An intensive family-based lifestyle intervention adopting low-resource strategies led to effective reduction in weight and waist circumference at 12 months, which has potential long-term benefits for preventing T2D. A higher number of attended sessions increased the effect on waist circumference, blood pressure and HbA1c.Item Spondylocostal Dysplasia in a 7-year-old Sri Lankan girl causing restrictive lung disease: A case report and review of the literature(Hindawi Pub. Corp., 2020) Kamalanathan, P.; Fernando, M.; Jayawardena, R.; Upasena, A.; Rajindrajith, S.; Mettananda, S.ABSTRACT: Spondylocostal dysplasia (SCD) is a rare costovertebral malformation characterised by short-trunk short stature. It is a recessively inherited disorder, and commonly identified disease-causing mutations are in DLL3 gene. The reported prevalence is 1 : 200,000 worldwide, and none was reported from Sri Lanka. We report a 7-year-old Sri Lankan girl with spondylocostal dysplasia presenting with short stature and scoliosis. Disproportionate short stature was noted with short upper segment and small thoracic cavity. Skeletal survey revealed fused vertebra involving T5-T6, T9-T10, and L3-L4. Butterfly vertebrae were noted in T2, T4, T6, and T9. Diagnosis of SCD was made based on classic radiological features including vertebral fusion and rib abnormalities. Spirometry was performed due to small thoracic cavity which showed results compatible with moderate to severe restrictive lung disease. The child did not report respiratory difficulties or recurrent chest infections up to the presentation. She was referred to an orthopaedic team which recommended conservative management with close follow-up. In conclusion, spondylocostal dysplasia should be considered in short-trunk short stature with rib abnormalities in the absence of limb shortening. Appropriate treatment and follow-up for restrictive lung disease would determine the long-term outcome.Item School-based physical activity intervention in 11-13-year-olds: study protocol for cluster randomized controlled trial(Medip Academy, 2019) Prasangi, M.; Dabare; Waidyatilaka, I.; Jayawardena, R.; Wickremasinghe, R.; Andrew, P.; Hills; Wickramasinghe, P.; Lanerolle, P.Background: Targeted strategies to enhance regular physical activity appear to be promising to promote health and well-being of adolescents. This article reports the design of a cluster randomised controlled trial to evaluate the effectiveness of a school-based physical activity programme on the rate and duration of moderate-to-vigorous physical activity, sitting time including screen time, and health-related physical fitness parameters among 11-13 year-old adolescents. Methods: This is a cluster randomized controlled trial conducted in 360 adolescents from government schools in the Colombo Municipal Council area, Sri Lanka. An individual school was considered as a unit of randomization and the 12 selected schools were randomly assigned to one of two groups: control (six schools) and intervention groups (six schools). The intervention group follows a physical activity programme for 30 minutes on three school days per week, for three consecutive months in addition to the standard practice. The primary outcomes are moderate-to-vigorous physical activity rate and duration and sitting time including screen time. Secondary outcomes are the health-related physical fitness parameters: cardiovascular fitness, muscle fitness and flexibility, and body composition. All the outcomes are measured at baseline and three-months following the intervention. Discussion: The outcomes of this study will be an evidence-based intervention programme with the potential to be incorporated into the national education system thus promoting health and well-being of adolescents in Sri Lanka. Trial Registration: Registered at the Sri Lanka Clinical Trials Registry (SLCTR/2018/028). Keywords: Physical activity, Adolescents, Physical fitness, Moderate-to-vigorous physical activity