Browsing by Author "Wickramasinghe, V.P."

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Association between early weight gain and later adiposity in Sri Lankan adolescents
(Cambridge University Press., 2021) Samaranayake, D.; Lanerolle, P.; Waidyatilaka, I.; de Lanerolle-Dias, M.; Hills, A. P.; Wickremasinghe, A.R.; Wickramasinghe, V.P.
ABSTRACT: Early growth pattern is increasingly recognized as a determinant of later obesity. This study aimed to identify the association between weight gain in early life and anthropometry, adiposity, leptin, and fasting insulin levels in adolescence. A cross-sectional study was conducted in 366 school children aged 11-13 years. Weight, height, and waist circumference (WC) were measured. Fat mass (FM) was assessed using bioelectrical impedance analysis. Blood was drawn after a 12-h fast for insulin and leptin assay. Birth weight and weight at 6 months and at 18 months were extracted from Child Health Development Records. An increase in weight SD score (SDS) by ≥0.67 was defined as accelerated weight gain. Linear mixed-effects modeling was used to predict anthropometry, adiposity, and metabolic outcomes using sex, pubertal status, accelerated weight gain as fixed factors; age, birth weight, and family income as fixed covariates, and school as a random factor. Children with accelerated weight gain between birth and 18 months had significantly higher body mass index (BMI) SDS, WC SDS, height SDS, %FM, fat mass index (FMI), fat free mass index (FFMI), and serum leptin levels in adolescence. Accelerated weight gain between 6 and 18 months was associated with higher BMI SDS, WC SDS, %FM, and FMI, but not with height SDS or FFMI. Accelerated weight gain at 0-6 months, in children with low birth weight, was associated with higher height SDS, BMI SDS, WC SDS, %FM, and FMI; in children with normal birth weight, it was associated with BMI SDS, WC SDS, height SDS, and FFMI, but not with %FM or FMI. Effects of accelerated weight gain in early life on anthropometry and adiposity in adolescence varied in different growth windows. Accelerated weight gain during 6-18 months was associated with higher FM rather than linear growth. Effects of accelerated weight gain between 0 and 6 months varied with birth weight. KEYWORDS: Early accelerated growth; adiposity; adolescence; birth weight; insulin; leptin; obesity.
Develepment and validation of a BIA prediction equation for 11-13 year old Sri Lankan girls
(Sri Lanka Medical Association, 2018) Samaranayake, D.; Dabare, H. P. M.; de Lanerolle-Dias, M.; Waidyatilaka, I.; Jayawardena, R.; Hills, A. P.; Wickremasinghe, A.R.; Lanerolle, P.; Wickramasinghe, V.P.
INTRODUCTION AND OBJECTIVES: Population-specific measures of body composition are important in management of childhood obesity. This study aimed to develop and validate a bioelectrical impedance analysis (BIA) equation to assess total body water (TBW) and fat mass (FM) in Sri Lankan girls aged 11-13 years. METHODS: Forty-six 11-13 year-old healthy school girls were purposively selected and randomly divided into model development (n=30) and model validation (n=l6) sub-samples. Weight, height and impedance using BIA were measured. TBW was determined and FM was derived through the criterion Deuterium-dilution technique. Prediction equations for TBW and FM were developed using impedance index (heightvimpedance; cm2/Q), weight and height as independent variables. Final equations were developed combining the two sub-samples. Validity was assessed using correlation coefficients, paired-samples T-test and Bland-Altman plots. RESULTS: In the validation sample, predicted TBW and FM showed significant correlations and did not significantly differ from reference values, Final prediction equation for TBW had a R2 of 92.3% and RMSE of l.035 while FM prediction equation had a R2 of 94.3% and RMSE of 1.38. TBW predicted from new equation (19.48± 3.45kg) was not significantly different from reference TBW (19.52±3.65kg) and the two measures were significantly correlated (r=0.975, p<0.001). Similarly, predicted FM (10.41±4.39kg) was not significantly different from reference FM (10.38±4.74kg) and predicted and reference values were significantly correlated (r=0.974, p<0.001). In both prediction equations, the majority ofresiduals were within mean± l.96SD. CONCLUSION: Newly developed prediction equations for BIA assessment of TBW and FM show high validity compared to reference technique.
Effects of probiotics combined with dietary and lifestyle modification on clinical, biochemical, and radiological parameters in obese children with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis: a randomized clinical trial
(Korean Pediatric Society, 2022) Rodrigo, T.; Samaranayake, D.; Seneviratne, S.N.; de Silva, A.P.; Fernando, J.; de Silva, H.J.; Jayasekera; Wickramasinghe, V.P.
Background: Childhood obesity is a global problem associated with metabolic abnormalities. The gut-liver axis is thought to play a major role in its pathogenesis. Probiotics are known to alter the gut microbiota and, therefore, could be a therapeutic option in the management of childhood obesity-related complications. Purpose: This double-blind randomized placebo-controlled trial evaluated the effects of probiotics on metabolic derangement in obese children with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH). Methods: Obese children with NAFLD/NASH treated at the nutrition clinic of the University Paediatric Unit at Lady Ridgeway Hospital, Colombo, were recruited. Anthropometry, body fat, metabolic derangement, and liver ultrasound scan (USS) results were evaluated at baseline and after 6 months. Transient elastography (FibroScan®) was performed on a subsample of these patients. Eighty-four patients were recruited and randomized into the probiotics (n = 43) and placebo (n = 41) groups. The mean age was 11.3±1.9 versus 12.1±1.5 years in the probiotic and placebo groups, respectively. Baseline parameters including liver disease stage on USS, body fat percentage, fasting blood sugar, lipid profile, liver function, and C-reactive protein showed no significant intergroup differences. Results: In the probiotic group, a statistically significant reduction in body mass index was noted from the baseline value. However, the reduction was not significant compared with the placebo group. There was a significant reduction in triglycerides, aspartate transaminase (AST), alanine aminotransferase (ALT), AST/ALT ratio, and alkaline phosphatase in the placebo group over the treatment period. Although the liver disease stage on USS improved from stage II-III to stage I in a small number of patients in the probiotic-treated group, transient elastography performed in a subsample did not demonstrate significant improvement in either group. Conclusion: Our results indicate that probiotics have no advantage over lifestyle modification for improving obesity-associated metabolic derangement in children.
Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: A Randomised, placebo-controlled, phase 3 trial
(J. Onwhyn, 2020) Biswal, S.; Borja-Tabora, C.; Martinez Vargas, L.; Velásquez, H.; Theresa Alera, M.; Sierra, V.; Johana Rodriguez-Arenales, E.; Yu, D.; Wickramasinghe, V.P.; Duarte Moreira, E. Jr.; Fernando, A. D.; Gunasekera, D.; Kosalaraksa, P.; Espinoza, F.; López-Medina, E.; Bravo, L.; Tuboi, S.; Hutagalung, Y.; Garbes, P.; Escudero, I.; Rauscher, M.; Bizjajeva, S.; LeFevre, I.; Borkowski, A.; Saez-Llorens, X.; Wallace, D.; TIDES study group
BACKGROUND: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years. METHODS: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4-16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927. FINDINGS: 20 099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19 021 (94·6%) were included in the per protocol analysis, and 20 071 (99·9%) in the safety set. The primary endpoint was achieved with an overall vaccine efficacy of 80·2% (95% CI 73·3 to 85·3; 61 cases of VCD in the TAK-003 group vs 149 cases of VCD in the placebo group). In the secondary endpoint assessment timeframe, an overall vaccine efficacy of 73·3% (95% CI 66·5 to 78·8) was observed. Analysis of secondary endpoints showed efficacies of 76·1% (95% CI 68·5 to 81·9) in individuals who were seropositive at baseline, 66·2% (49·1 to 77·5) in individuals who were seronegative at baseline, 90·4% (82·6 to 94·7) against hospitalised dengue, and 85·9% (31·9 to 97·1) against dengue haemorrhagic fever. Efficacy varied by individual serotypes (DENV 1, 69·8% [95% CI 54·8 to 79·9]; DENV 2, 95·1% [89·9 to 97·6]; DENV 3, 48·9% [27·2 to 64·1]; DENV 4, 51·0% [-69·4 to 85·8]). Cumulative rates of serious adverse events were similar in TAK-003 (4·0%) and placebo (4·8%) recipients, and were consistent with expected medical disorders in the study population. Infection was the most frequent reason leading to serious adverse events. 20 participants (<0·1% of the safety set) were withdrawn from the trial due to 21 adverse events by the end of part two; 14 of these participants received TAK-003 and six received placebo. INTERPRITATION: TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation. Vaccine efficacy varied by serotype, warranting continued follow-up to assess longer-term vaccine performance. FUNDING: Takeda Vaccines.
Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4·5-year results from a phase 3, randomised, double-blind, placebo-controlled trial
(Elsevier, 2024) Tricou, V.; Yu, D.; Reynales, H.; Biswal, S.; Saez-Llorens, X.; Sirivichayakul, C.; Lopez, P.; Borja-Tabora, C.; Bravo, L.; Kosalaraksa, P.; Vargas, L.M.; Alera, M.T.; Rivera, L.; Watanaveeradej, V.; Dietze, R.; Fernando, L.; Wickramasinghe, V.P.; Moreira, E.D.; Fernando, A.D.; Gunasekera, D.; Luz, K.; Oliveira, A.L.; Tuboi, S.; Escudero, I.; Hutagalung, Y.; Lloyd, E.; Rauscher, M.; Zent, O.; Folschweiller, N.; LeFevre, I.; Espinoza, F.; Wallace, D.
BACKGROUND: About half of the world's population lives in dengue-endemic areas. We aimed to evaluate the long-term efficacy and safety of two doses of the tetravalent dengue vaccine TAK-003 in preventing symptomatic dengue disease of any severity and due to any dengue virus (DENV) serotypes in children and adolescents. METHODS: In this ongoing double-blind, randomised, placebo-controlled trial, we enrolled healthy participants aged 4-16 years at 26 medical and research centres across eight dengue-endemic countries (Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). The main exclusion criteria were febrile illness (body temperature ≥38°C) at the time of randomisation, hypersensitivity or allergy to any of the vaccine components, pregnancy or breastfeeding, serious chronic or progressive disease, impaired or altered immune function, and previous receipt of a dengue vaccine. Participants were randomly assigned 2:1 (stratified by age and region) using an interactive web response system and dynamic block assignment to receive two subcutaneous doses of TAK-003 or placebo 3 months apart. Investigators, participants, and their parents or legal guardians were blinded to group assignments. Active febrile illness surveillance and RT-PCR testing of febrile illness episodes were performed for identification of virologically confirmed dengue. Efficacy outcomes were assessed in the safety analysis set (all randomly assigned participants who received ≥1 dose) and the per protocol set (all participants who had no major protocol violations), and included cumulative vaccine efficacy from first vaccination to approximately 4·5 years after the second vaccination. Serious adverse events were monitored throughout. This study is registered with ClinicalTrials.gov, NCT02747927. FINDINGS: Between Sept 7, 2016, and March 31, 2017, 20 099 participants were randomly assigned (TAK-003, n=13 401; placebo, n=6698). 20 071 participants (10 142 [50·5%] males; 9929 [49·5%] females; safety set) received TAK-003 or placebo, with 18 257 (91·0%) completing approximately 4·5 years of follow-up after the second vaccination (TAK-003, 12 177/13 380; placebo, 6080/6687). Overall, 1007 (placebo: 560; TAK-003: 447) of 27 684 febrile illnesses reported were virologically confirmed dengue, with 188 cases (placebo: 142; TAK-003: 46) requiring hospitalisation. Cumulative vaccine efficacy was 61·2% (95% CI 56·0-65·8) against virologically confirmed dengue and 84·1% (77·8-88·6) against hospitalised virologically confirmed dengue; corresponding efficacies were 53·5% (41·6-62·9) and 79·3% (63·5-88·2) in baseline seronegative participants (safety set). In an exploratory analysis, vaccine efficacy was shown against all four serotypes in baseline seropositive participants. In baseline seronegative participants, vaccine efficacy was shown against DENV-1 and DENV-2 but was not observed against DENV-3 and low incidence precluded evaluation against DENV-4. During part 3 of the trial (approximately 22-57 months after the first vaccination), serious adverse events were reported for 664 (5·0%) of 13 380 TAK-003 recipients and 396 (5·9%) of 6687 placebo recipients; 17 deaths (6 in the placebo group and 11 in the TAK-003 group) were reported, none were considered study-vaccine related. INTERPRETATION: TAK-003 demonstrated long-term efficacy and safety against all four DENV serotypes in previously exposed individuals and against DENV-1 and DENV-2 in dengue-naive individuals. FUNDING: Takeda Vaccines. TRANSLATIONS: For the Portuguese, Spanish translations and plain language summary of the abstract see Supplementary Materials section.
Metformin: use as a pharmacological agent in management of childhood obesity
(Sri Lanka Medical Association, 2016) Warnakulasuriya, L.S.; Fernando, M.A.M.; Adikaram, A.V.N.; Thawfeek, A.R.M.; Anurasiri, W.M.L.; Silva, K.D.R.R.; Sirasa, M.S.F.; Samaranayake, D.; Wickramasinghe, V.P.
INTRODUCTION: Childhood obesity-related metabolic derangements are increasing among South Asian populations. Dietary and physical activity plans have limited effect. OBJECTIVES: This study aims to assess effectiveness of metformin against placebo in management of childhood obesity among 8-16 year-old children in Gampaha District. METHOD: A triple-blinded control trial was conducted in a sample of 150 obese school children. After 12-hour overnight fast, blood was drawn for fasting blood glucose (FBS) and lipid profile. 2-hour OGTT was done. Anthropometry, fat mass (FM) and blood pressure were measured. Children randomly received either age-adjusted dose of metformin or placebo, with advice on diet and physical activity. Anthropometry and blood investigations were repeated at 6 and 12 months. Mean difference in outcome measures, adjusted for baseline values were compared between the two groups using ANOVA. RESULTS: There were 84/150 boys and 25 (16.7%) had metabolic syndrome. A statistically significant adjusted mean reduction was observed in metformin group compared to placebo, in weight (-0.991 vs 1.394, p=0.000), BMI-SDS (-0.287 vs -0.116, p=0.000), percentage FM-SDS (-0.092 vs 0.016, p=0.04), systolic BP (-0.415 vs 0.015, p=0.015), total cholesterol (-36.48 vs -27.32, p=0.001), LDL (-26.06 vs -17.22, p=0.001) and hsCRP(-0.143 vs 0.008, p=0.013) at six months, and in BMI-SDS (-370 vs -0.222, p=0.001), WC-SDS (-0.473 vs -0.337, p=0.018), systolic BP (-0.834 vs -0.477, p=0.023) and triglycerides (-29.30 vs-12,72, p=0.019) at 12 months. CONCLUSIONS: Metformin compared to placebo has beneficial effects on anthropometric and metabolic indicators in the management of childhood obesity.
Relationship between objectively measured physical activity, sedentary behaviour and body mass index among 11-13 year-old adolescents in Colombo
(Sri Lanka Medical Association., 2019) Dabare, H.P.M.; Waidyatilaka, P.H.I.U.; de Lanerolle-Dias, M.; Wickremasinghe, R.; Jayawardena, R.; Hills, A.P.; Lanerolle, P.; Wickramasinghe, V.P.
INTRODUCTION & OBJECTIVES: Inadequate physical activity (PA) and sedentary behaviour (SB) are attributed to the high prevalence of adolescent obesity in the world. This study aimed to identify the relationship between PA intensity, SB and body mass index (BMI) among I I -13 year-old adolescents in Colombo, Sri Lanka. METHODS: A purposive sample of 95 adolescent school girls and boys were recruited from the Colombo Municipal Council Area. Time spent on moderate-to-vigorous PA (MVPA) and SB were determined by accelerometers (Actigraph-WGT3X-BT) worn on the waist for 10 consecutive days. Height and weight were measured using the standard methodology and BMI was calculated. RESULTS: The sample consisted of 51.6 % of boys (n=49). Mean BMI of the boys was 17.2 ± 3.2 kgm-2 and girls was 17.2 ± 3.2 kgm-2. A significantly (p< 0.05) lower SB (487.4 ± 101.4 min/day vs. 596.4 ± 83.8 min/day) and a significantly higher time spent on MVPA (31.8 ± 15.1 min/day vs. 15 ± 6.7 min/day) were observed among normal weight (NW) girls compared to overweight (OW) girls. Similarly, compared to the OW boys, NW boys had a significantly (p< 0.05) lower SB (578.5 ± 94.1 min/day vs. 696.4 ± 87.4 min/day) and a significantly higher time spent in MVPA (52.9 ± 19.3 min/day vs. 23.4 ± 6.3 min/day). CONCLUSION: Effective strategies should be implemented to reduce SB and increase PA in order to correct the obsogenic behaviour among the adolescents.
Suitability of selection criteria as a measure of medical graduates: University of Colombo
(University of Colombo, 2006) Mettananda, D.S.G.; Wickramasinghe, V.P.; Kudolugoda Arachchi, J.; Lamabadusuriya, S.P.; Ajanthan, R.; Kottahachchi, D.
A prime obstacle faced by a medical educator is selecting the right student to be trained as a doctor, and the general consensus is that this is also the most difficult task. This study was designed to evaluate the effects of selected outcome measures on outcome performance of medical undergraduates of the University of Colombo. A retrospective cohort study was conducted using the performance (marks) of students of 4 batches GCE (A/L) 1993 through to 1996). GCE (A/L) aggregate marks, attempt of entry, district of entry, English language proficiency and sex were tested as predictors of success. Results of main assessments were considered as measures of success. Relationship between outcome measures and outcome predictors were assessed using the multiple logistic regression model. Data of 699 students were analyzed and 82% of students entered from the Colombo district. A higher percentage of first attempters (at GCE A/L) performed well and obtained classes. Entering medical school from first two GCE A/L examination attempts was a significant positive predictor of passing any examination (odds ratio 3.2 to 7.5) or obtaining honors (odds ratio 2.8 to 16.0). Attempt of entry predicted 5.4% of the outcome (pass or fail) in university performance. Correlation between the GCE A/L aggregate mark and the student's position in order of merit for the internship appointments was -0.37 (p<0.001). A combination of factors should be used in the selection process of students to embark on the undergraduate process as any single factor is a poor predictor of outcome of performance. We believe that the number of attempts allowed to sit for GCE A/L in order to gain entry to a medical school as well as other degree courses should be confined to two attempts.
Validity of BIA prediction equations in determining the fat mass of 11-13 year old Sri Lankan girls
(Sri Lanka Medical Association, 2018) Samaranayake, D.; Dabare, H. P. M.; de Lanerolle-Dias, M.; Waidyatilaka, I.; Jayawardena, R.; Hills, A. P.; Wickremasinghe, A.R.; Wickramasinghe, V.P.; Lanerolle, P.
INTRODUCTION AND OBJECTIVES: Bioelectrical impedance analysis (BIA) is a simple body composition assessment method, based on use of prediction equations. Validation of equations for the specific populations is important for accurate assessment. This study aimed to determine the validity of available BIA equations in assessing the fat mass (FM) in Sri Lankan girls aged 11-13 years. METHODS: Forty-six 11-13 year-old healthy school girls were purposively selected. Weight, height and impedance using BIA were measured. Total body water was determined and FM was derived through the criterion Deuterium dilution technique. Twelve BIA prediction equations applicable to the age and sex were identified from literature. Predicted FM calculated according to each equation was compared with reference FM (assessed through isotope dilution), and validity was assessed using correlation coefficients, paired samples T-test and Bland-Altman plots. RESULTS: FM predicted by all twelve equations was significantly correlated (r>0.93, p<0.05) with reference FM. Mean (±SD) bias of predicted FM ranged from -5.32 (±1.79) kg to 5.8 (±2.1 l) kg. Only four equations predicted mean FM values that were not significantly different from the mean reference FM values, the mean bias (±SD) ranging from -0.21 (±2.23) kg to 0.06 (±l.72) kg. Of these four prediction equations, only one had a symmetric, uniform distribution of error within the ±l .96 SD limits in the Bland-Altman analysis. CONCLUSION: Most available BIA prediction equations are unsatisfactory for use in the local context. Cross validation of existing prediction equations before use or development of BIA prediction equations to suit the local populations is recommended.