Impact of short-term application of continuous glucose monitoring system(CGMS) on long-term glycemic profile in adolescents and adults with type 1 diabetes mellitus: An open-label randomized control cross over study.

AIMS: The use of Continuous Glucose Monitoring System (CGMS) improves glycemic parameters in Type 1 Diabetes Mellitus (T1D), but the cost is prohibitive. Here, we investigated the effect of short-term application of real-time and intermittently-scanned CGMS (rt and is-CGMS) in T1D individuals on change in HbA1c at the end of 3 months. METHODS: T1D individuals were randomized into three groups in a ratio of 1:1:2 - Group A (rt-CGMS for 2 weeks initially, followed by is-CGMS for 2 weeks at 3 months), Group B (is-CGMS for 2 weeks initially followed by rt-CGMS for 2 weeks at 3 months) and Group C (only self-monitoring of blood glucose), respectively. HbA1c at baseline, 3, and 6 months were compared. RESULTS: Out of a total 68 T1D patients, HbA1c decreased significantly in groups A and B at 6 months compared to the baseline, but not in group C. HbA1c was significantly lower in Group A compared to Group C at 3 and 6 months. Fructosamine levels significantly decreased in Group B before and after cross-over. Glycemic variability indices improved significantly after cross-over from is-CGMS to rt-CGMS. CONCLUSION: Intermittent application of CGMS for 2 weeks improves short- and long-term blood glucose control in T1D.

Efficacy of zoledronate, denosumab or teriparatide in postmenopausal women with type 2 diabetes mellitus at high risk of fragility fractures: protocol of an open, blinded endpoint randomized controlled pilot trial.

Background: People with type 2 diabetes (T2D) are at high risk of fragility fractures; however, there are no randomized controlled trials evaluating the efficacy of anti-osteoporosis drugs as a primary pre-specified endpoint in T2D. Objectives: To compare the efficacy of anti-osteoporotic drugs in postmenopausal women with T2D. Design: Prospective, randomized, open, blinded endpoint clinical pilot trial. Methods: Postmenopausal women (⩾50 years) with T2D (duration ⩾5 years), HbA1c 7-10%, eGFR ⩾45 mL/min/1.73 m2 and prior vertebral (clinical/morphometric), hip, radius, humeral fragility fracture or bone mineral density (BMD) T-score (adjusted for diabetes) at lumbar spine/femoral neck ⩽-2.5 and high FRAX score will be eligible for inclusion. Subjects with secondary causes of osteoporosis, prior exposure to bone-active therapies or history of use of glucocorticoids/pioglitazone/thiazides/canagliflozin will be excluded. Finally, eligible subjects will undergo estimation of serum calcium, phosphate, alkaline phosphatase, parathyroid hormone, 25-hydroxyvitamin D and bone turnover markers (BTMs) (total procollagen type I N-propeptide, ß-CTX) along with trabecular bone score (TBS) and high-resolution peripheral quantitative computed tomography (HR-pQCT) of non-dominant hand and leg. After a 2-week run in phase, they will be randomized in a 1:1:1:1 ratio to receive yearly zoledronate, or biannually denosumab or daily teriparatide (in addition to standard of care, i.e., calcium 1000 mg/day and cholecalciferol 1000 IU/day) or only standard of care (control). The primary endpoints will be change in areal BMD and frequency of incident fractures at 18 months. The secondary endpoints will be change in HR-pQCT parameters, TBS and BTMs at 18 months. Adverse events will be recorded for all randomized participants. Ethics: The study has been approved by the Institute Ethics Committee. Written informed consent will be obtained from each participant. Discussion: The trial is expected to provide information regarding optimal anti-osteoporotic therapy in people with T2D and bone fragility. Registration: Prospectively registered in Clinical Trial Registry of India (CTRI/2022/02/039978).

Role of Interleukin-6 in Prediction of Early Complications After Minimally Invasive Oesophagectomy-a Pilot Study.

Infectious complications following oesophagectomy are associated with significant morbidity. Early prediction of these complications may mitigate significant morbidity and mortality. Patients undergoing minimally invasive oesophagectomy for carcinoma oesophagus between January 2019 and June 2020 were included in the study. All patients underwent standard preoperative investigations and preparation. Post-operative complications including infectious complications were recorded. Association of post-operative serum interleukin-6 (IL-6) levels with post-operative complications were analysed. A total of twenty-two participants were included in the study (median age; 51 years, 13 (%) male). The tumour site was middle 1/3rd of oesophagus in 13 (59.1%), lower 1/3rd of oesophagus in 9 (40.9%). The tumour histology was squamous cell carcinoma in all patients. Eight (36.4 %) patients developed major complications and five of them developed anastomotic leak. IL-6 levels were significantly higher on POD 3 in patients who developed major complications (p = 0.009) and anastomotic leak (p = 0.031). At receiver operating characteristic curve (ROC curve) analysis, an IL-6 cut-off level of 36.4 pg/ml on POD 3 yielded a sensitivity of 87% and a specificity of 79% for the prediction of major complication and cut-off level of 44.3 pg/ml on POD 3 yielded a sensitivity of 80% and a specificity of 82% for the prediction of anastomotic leak. A high post-operative IL-6 level helps in the prediction of major complications and cervical oesophagogastric anastomotic leak.

Incidence and risk factors for dysglycaemia in Asian-Indians: a 10-year population-based prospective cohort study.

BACKGROUND: Diabetes prevalence estimates suggest an increasing trend in South-East Asia region, but studies on its incidence are limited. The current study aims to estimate the incidence of type 2 diabetes and pre-diabetes in a population-based cohort from India. METHODS: A subset of Chandigarh Urban Diabetes Study cohort (n=1878) with normoglycaemia or pre-diabetes at baseline was prospectively followed after a median of 11 (0.5-11) years. Diabetes and pre-diabetes were diagnosed as per WHO guidelines. The incidence with 95% CI was calculated in 1000 person-years and Cox proportional hazard model was used to find the association between the risk factors and progression to pre-diabetes and diabetes. RESULTS: The incidence of diabetes, pre-diabetes and dysglycaemia (either pre-diabetes or diabetes) was 21.6 (17.8-26.1), 18.8 (14.8-23.4) and 31.7 (26.5-37.6) per 1000 person-years, respectively. Age (HR 1.02, 95% CI 1.01 to 1.04), family history of diabetes (HR 1.56, 95% CI 1.09 to 2.25) and sedentary lifestyle (HR 1.51, 95% CI 1.05 to 2.17) predicted conversion from normoglycaemia to dysglycaemia, while obesity (HR 2.43, 95% CI 1.21 to 4.89) predicted conversion from pre-diabetes to diabetes. CONCLUSION: A high incidence of diabetes and pre-diabetes in Asian-Indians suggests a faster conversion rate to dysglycaemia, which is partly explained by sedentary lifestyle and consequent obesity in these individuals. The high incidence rates call for a pressing need for public health interventions targeting modifiable risk factors.

Dose-Response Evaluation of Scopoletin, a Phytochemical, in a High-Fructose High-Fat Diet-Induced Dyslipidemia Model in Wistar Rats.

The putative hypolipidemic properties of scopoletin have not been fully confirmed due to a lack of validation in an irreversible chronic hyperlipidemia animal model. The druggability also needs to be studied in terms of bioavailability in the vascular compartment. Accordingly, we conducted a study to assess the hypolipidemic and pharmacokinetic behavior of scopoletin in the high-fructose high-fat diet (HFHFD)-induced dyslipidemia model in Wistar rats. A total of 42 rats were studied, with 6 in each of the 7 groups. A 60-day HFHFD opted for induction of dyslipidemia. Group I and groups II-VII received normal rat chow diet and HFHFD, respectively. Oral scopoletin (1, 5, 10 mg/kg) and atorvastatin 5 mg/kg were administered in groups III-VI, respectively, once daily for the next 15 days. A separate group, group VII, was used for the pharmacokinetic assessment comparing the scopoletin 10 mg/kg intraperitoneally (IP) in group VII versus the oral (group V). Pharmacokinetic blood sampling was performed on the 10th day of continuous once-daily therapy. Rats were sacrificed for the histological examination. All three scopoletin dosages significantly decreased the total cholesterol, low-density lipoproteins, and triglycerides (P < .05 for all), but not in a dose-dependent manner. Atherogenic Index of plasma, Castelli's risk indices, and histopathological findings confirmed the protective effect of scopoletin. The IP administration showed a 23.18% higher exposure than the oral route (P < .001 for area under the curve and P < .05 for concentration-maximum). This study confirms the hypolipidemic efficacy of scopoletin in a more robust irreversible model of dyslipidemia. Scopoletin's gut absorption in the disease state may also boost the initial phase exploratory clinical trial.

Incidence and predictors of metabolic syndrome in Asian-Indians: a 10-year population-based prospective cohort study.

Background: Metabolic syndrome represents aggregation of risk factors associated with an increased risk of developing type 2 diabetes mellitus (DM) and atherosclerotic cardiovascular disease (ASCVD). Assessing its incidence is an effective way for estimating the future burden of DM and ASCVD and understanding their secular trends and effect of public health measures on halting the evolution of risk factors. The present study aimed to estimate the incidence of metabolic syndrome and its predictors using a population-based cohort. Methods: A subset of Chandigarh Urban Diabetes Study cohort (n = 1023) without diabetes or metabolic syndrome was prospectively evaluated after a mean of 10.7 years. Metabolic syndrome was defined as per International Diabetes Federation criteria and diabetes as per American Diabetes Association standards. The incidence was calculated in 1000 person years, and multivariate logistic regression was used to estimate the strength of association between incident metabolic syndrome and risk factors. Results: In the followed-up individuals (n = 303), incidence of metabolic syndrome was 32.1 per 1000 person years (95% CI 26.3-38.7 per 1000 person years). Amongst those developing metabolic syndrome, ≥4 components were present in 52% individuals, with low HDL-C being the most common abnormality. Those with metabolic syndrome had a five-time higher risk of diabetes (OR: 4.94; 95% CI: 2.27-9.96; p < 0.001) and a threefold higher risk of hypertension (OR: 2.67; 95% CI: 1.30-5.48; p = 0.006). Conclusion: Asian-Indians have a high incidence rate of metabolic syndrome, which is associated with sedentary lifestyle and consequent central obesity.

ASCITIC AND SERUM LEVELS OF TUMOR BIOMARKERS (CA 72-4, CA 19-9, CEA AND CA 125) IN DISCRIMINATION OF CAUSE OF ASCITES: A PROSPECTIVE STUDY.

BACKGROUND: The role of ascitic and serum levels of various tumour biomarkers in the discrimination of cause of ascites is not well established. OBJECTIVE: To evaluate the role of serum and ascitic levels of tumor biomarkers (CA 72-4, CA 19-9, CEA and CA 125) in discrimination of cause of ascites. METHODS: A prospective study was conducted in consecutive patients presenting with ascites. Serum and ascitic levels of CA 19-9, CA 125, CA 72-4 and carcinoembryonic antigen (CEA) were determined at the presentation. The patients with cirrhotic ascites, tuberculous peritonitis (TBP) and peritoneal carcinomatosis (PC) were eventually included in analysis. RESULTS: Of the 93 patients (58 males, mean age 47 years) included, the underlying cause was cirrhosis in 31, PC in 42 and peritoneal tuberculosis in 20. The best cutoff for discriminating benign and malignant ascites for serum CEA, CA 19-9 and CA 72-4 were 6.7 ng/mL, 108 IU/mL and 8.9 IU/mL, respectively. The best cutoff for discriminating benign and malignant ascites for ascitic CA 125, CEA, CA 19-9 and CA 72-4 were 623 IU/mL, 8.7 ng/mL, 33.2 IU/mL and 7 IU/mL, respectively. CONCLUSION: The performance of single biomarker for the prediction of underlying PC is low but a combination of serum CA 19-9 and CA 72-4 best predicted the presence of peritoneal carcinomatosis.

Níveis ascíticos e soros de biomarcadores tumorais (CA 72-4, CA 19-9, CEA e CA 125) em discriminação de causa de ascites: um estudo prospectivo / Ascitic and serum levels of tumor biomarkers (ca 72-4, ca 19-9, cea and ca 125) in discrimination of cause of ascites: a prospective study

ABSTRACT Background: The role of ascitic and serum levels of various tumour biomarkers in the discrimination of cause of ascites is not well established. Objective: To evaluate the role of serum and ascitic levels of tumor biomarkers (CA 72-4, CA 19-9, CEA and CA 125) in discrimination of cause of ascites. Methods: A prospective study was conducted in consecutive patients presenting with ascites. Serum and ascitic levels of CA 19-9, CA 125, CA 72-4 and carcinoembryonic antigen (CEA) were determined at the presentation. The patients with cirrhotic ascites, tuberculous peritonitis (TBP) and peritoneal carcinomatosis (PC) were eventually included in analysis. Results: Of the 93 patients (58 males, mean age 47 years) included, the underlying cause was cirrhosis in 31, PC in 42 and peritoneal tuberculosis in 20. The best cutoff for discriminating benign and malignant ascites for serum CEA, CA 19-9 and CA 72-4 were 6.7 ng/mL, 108 IU/mL and 8.9 IU/mL, respectively. The best cutoff for discriminating benign and malignant ascites for ascitic CA 125, CEA, CA 19-9 and CA 72-4 were 623 IU/mL, 8.7 ng/mL, 33.2 IU/mL and 7 IU/mL, respectively. Conclusion: The performance of single biomarker for the prediction of underlying PC is low but a combination of serum CA 19-9 and CA 72-4 best predicted the presence of peritoneal carcinomatosis.

RESUMO Contexto: O papel dos níveis ascíticos e séricos de vários biomarcadores de tumores na discriminação da causa das ascites não está bem estabelecido. Objetivo: Avaliar o papel dos níveis séricos e ascíticos de biomarcadores tumorais (CA 72-4, CA 19-9, CEA e CA 125) na discriminação da causa das ascites. Métodos: Estudo prospectivo foi realizado em pacientes consecutivos que apresentaram ascite. Foram determinados níveis do soro e ascítico de CA 19-9, CA 125, CA 72-4 e antígeno carcinoembrínico (CEA). Os pacientes com ascites cirróticas, peritonite tuberculosa e carcinomatose peritoneal (CP) foram eventualmente incluídos na análise. Resultados: Dos 93 pacientes (58 homens, média de idade 47 anos) incluídos, a causa básica foi cirrose em 31, CP em 42 e tuberculose peritoneal em 20. O melhor corte para discriminação de ascites benignas e malignas para soro CEA, CA 19-9 e CA 72-4 foram 6,7 ng/mL, 108 UI/mL e 8,9 UI/mL, respectivamente. O melhor corte para discriminação de ascites benignas e malignas para CA 125 ascitico, CEA, CA 19-9 e CA 72-4 foram 623 UI/mL, 8,7 ng/mL, 33,2 UI/mL e 7 UI/mL, respectivamente. Conclusão: O desempenho do biomarcador único para a previsão do CP subjacente é baixo, mas uma combinação de soro CA 19-9 e CA 72-4 melhor previu a presença de carcinomatose peritoneal.

COVID-19-related dynamic coagulation disturbances and anticoagulation strategies using conventional D-dimer and point-of-care Sonoclot tests: a prospective cohort study.

OBJECTIVES: Coagulation changes associated with COVID-19 suggest the presence of a hypercoagulable state with pulmonary microthrombosis and thromboembolic complications. We assessed the dynamic association of COVID-19-related coagulation abnormalities with respiratory failure and mortality. DESIGN: Single-centre, prospective cohort study with descriptive analysis and logistic regression. SETTING: Tertiary care hospital, North India. PARTICIPANTS: Patients with COVID-19 pneumonia requiring intensive care unit (ICU) admission between August 2020 and November 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: We compared the coagulation abnormalities using standard coagulation tests like prothrombin time, D-dimer, platelet count, etc and point-of-care global coagulation test, Sonoclot (glass beaded(gb) and heparinase-treated(h)). Incidence of thromboembolic or bleeding events and presence of endogenous heparinoids were assessed. Cox proportional Hazards test was used to assess the predictors of 28-day mortality. MEASUREMENT: All patients underwent Sonoclot (glass beaded) test at admission apart from the routine investigations. In patients at risk of thromboembolic or bleeding phenomena, paired tests were performed at day 1 and 3 with Sonoclot. Activated clotting time (ACT) <110 s and peak amplitude >75 units were used as the cut-off for hypercoagulable state. Presence of heparin-like effect (HLE) was defined by a correction of ACT ≥40 s in h-Sonoclot. RESULTS: Of 215 patients admitted to ICU, we included 74 treatment naive subjects. A procoagulant profile was seen in 45.5% (n=5), 32.4% (n=11) and 20.7% (n=6) in low-flow, high-flow and invasive ventilation groups. Paired Sonoclot assays in a subgroup of 33 patients demonstrated the presence of HLE in 17 (51.5%) and 20 (62.5%) at day 1 and 3, respectively. HLE (day 1) was noted in 59% of those who bled during the disease course. Mortality was observed only in the invasive ventilation group (16, 55.2%) with overall mortality of 21.6%. HLE predicted the need for mechanical ventilation (HR 1.2 CI 1.04 to 1.4 p=0.00). On multivariate analysis, the presence of HLE (HR 1.01; CI 1.006 to 1.030; p=0.025), increased C reactive protein (HR 1.040; CI 1.020 to 1.090; p=0.014), decreased platelet function (HR 0.901; CI 0.702 to 1.100 p=0.045) predicted mortality at 28days. CONCLUSION: HLE contributed to hypocoagulable effect and associated with the need for invasive ventilation and mortality in patients with severe COVID-19 pneumonia. TRIAL REGISTRATION: NCT04668404; ClinicalTrials.gov.in. Available from https://clinicaltrials.gov/ct2/show/NCT04668404.

Association of serum BDNF level and Val66Met polymorphism with response to treatment in patients of major depressive disease: A step towards personalized therapy.

BACKGROUND: Major depressive disorder (MDD) is one of the most common psychiatric disorders and only less than 50% of MDD patients achieve remission after the first antidepressant trial. Hence, it is important to understand the factors associated with response to various antidepressant medications. Brain-derived neurotrophic factor (BDNF) is a member of the neurotrophin family. BDNF and Val66Met polymorphism in the BDNF gene has a role in MDD. This study aimed to determine the association of rs6265 polymorphism and serum BDNF level with response to treatment in MDD patients. METHODS: The study included 200 subjects, consisting of 100 MDD patients treated with oral antidepressants and 50 treated with ECT, and 50 healthy controls. Serum BDNF levels were estimated using ELISA and rs6265 polymorphism was genotyped using tetra-primer ARMS PCR. RESULTS: Val66Met polymorphism had an association with MDD, and in MDD patients with Met allele was associated with a better response to antidepressants. Serum BDNF level was significantly higher in MDD patients compared to healthy individuals. In MDD patients, lower serum BDNF level was associated with better ECT outcomes. CONCLUSIONS: Val66Met polymorphism in BDNF gene and serum BDNF level has the potential to be used as a biomarker for the prediction of response to oral antidepressants and ECT in MDD patients. The presence of the Met allele might be used to predict the chances of occurrence of MDD in the future. The results of our study might form a basis for the development of personalized treatment for MDD in the future.

SERUM PROCALCITONIN AS A PROGNOSTIC MARKER IN ACUTE SEVERE ULCERATIVE COLITIS: A PROSPECTIVE STUDY.

BACKGROUND: Procalcitonin may be increased in active ulcerative colitis (UC). We investigated the role of procalcitonin in predicting response in acute severe UC (ASUC). METHODS: Consecutive patients with ASUC diagnosed on basis of Truelove and Witts criteria were enrolled. Serum procalcitonin levels for consecutive patients were measured at admission and day 3. We assessed role of procalcitonin values at presentation and at day 3 in assessing response on day 3 (Oxford's criteria) and need for second line therapy (day 28). RESULTS: Of fifty patients (23 males, mean age: 35.98±13.8 years), 16 did not respond (day 3). Ten (20%) patients required second-line therapy. Baseline procalcitonin was significantly associated with response on day 3 (P=0.016). There was no association between day 1 or day 3 procalcitonin and need for second-line rescue therapy. CONCLUSION: Serial procalcitonin is not an effective biomarker for predicting outcomes or need for second line therapy in ASUC.

A procalcitonina sérica como marcador prognóstico na colite ulcerativa aguda / Serum procalcitonin as a prognostic marker in acute severe ulcerative colitis: a prospective study

ABSTRACT Background Procalcitonin may be increased in active ulcerative colitis (UC). We investigated the role of procalcitonin in predicting response in acute severe UC (ASUC). Methods Consecutive patients with ASUC diagnosed on basis of Truelove and Witts criteria were enrolled. Serum procalcitonin levels for consecutive patients were measured at admission and day 3. We assessed role of procalcitonin values at presentation and at day 3 in assessing response on day 3 (Oxford's criteria) and need for second line therapy (day 28). Results Of fifty patients (23 males, mean age: 35.98±13.8 years), 16 did not respond (day 3). Ten (20%) patients required second-line therapy. Baseline procalcitonin was significantly associated with response on day 3 (P=0.016). There was no association between day 1 or day 3 procalcitonin and need for second-line rescue therapy. Conclusion Serial procalcitonin is not an effective biomarker for predicting outcomes or need for second line therapy in ASUC.

RESUMO Contexto A procalcitonina pode estar aumentada em colite ulcerativa ativa. Investigamos o papel da procalcitonina na previsão de resposta na colite ulcerativa aguda grave. Métodos Foram inscritos pacientes consecutivos com colite ulcerativa aguda grave diagnosticados com base nos critérios de Truelove e Witts. Os níveis de procalcitonina sérica dos pacientes foram medidos consecutivamente na internação e no terceiro dia. Avaliamos o papel dos valores procalcitonina na apresentação e na avaliação da resposta no terceiro dia (critérios de Oxford) e necessidade de terapia de segunda linha (dia 28). Resultados Dos 50 pacientes (23 homens, idade média: 35,98±13,8 anos), 16 não responderam (terceiro dia). Dez pacientes (20%) necessitaram de terapia de segunda linha. A procalcitonina de linha de base foi significativamente associada à resposta no terceiro dia (P=0,016). Não houve associação entre o primeiro dia ou o terceiro dia de procalcitonina e necessidade de terapia de resgate de segunda linha. Conclusão A procalcitonina sérica não é um biomarcador eficaz para prever desfechos ou necessidade de terapia de segunda linha em colite ulcerativa aguda grave.

Abdominal obesity and incident cardio-metabolic disorders in Asian-Indians: A 10-years prospective cohort study.

BACKGROUND AND AIMS: To estimate the strength of association between abdominal obesity and incident cardio-metabolic diseases. METHODS: A subset of Chandigarh Urban Diabetes study cohort (n = 543) was followed after a mean of 10.7 years for development of diabetes, prediabetes, dysglycaemia (either prediabetes or diabetes), hypertension and atherosclerotic cardiovascular disease (ASCVD). Diabetes and prediabetes were defined as per American Diabetes Association consulting group criteria, hypertension as blood pressure of ≥140/90 mmHg and ASCVD after review of medical records. Abdominal obesity was defined as waist circumference of ≥80 cm and ≥90 cm in females and males, respectively. RESULTS: As compared to non-obese (n = 209), abdominally obese individuals (n = 334) had a higher risk of diabetes [RR:1.82(1.28-2.57)], prediabetes [RR:1.40(1.05-1.85)], dysglycaemia [ RR:1.38(1.07-1.78)], hypertension [RR: 1.84(1.30-2.59)] and ASCVD [RR:2.12(1.02-4.4)]. The optimal cut-off of waist circumference for detecting incident diabetes, hypertension and ASCVD in females was 88 cm, 85 cm and 91 cm, respectively; while in males it was 90 cm, 87 cm and 94 cm, respectively. CONCLUSION: In Asian-Indians, abdominal obesity as defined by waist circumference of ≥90 cm and ≥80 cm in males and females, respectively is associated with a twofold higher risk of diabetes, hypertension and ASCVD. In addition, the current-cut-offs of waist circumference to define abdominal obesity need reconsideration to optimally identify individuals at a higher risk of cardio-metabolic diseases. However, a high attrition rate represents a major limitation.

COVID-19 associated variations in liver function parameters: a retrospective study.

BACKGROUND: Characteristics of laboratory findings of COVID-19 patients are of great significance for diagnosis and treatment. Studies that have analysed the variations in hepatic profile in correlation with the inflammatory markers in SARS-CoV-2 are limited. METHODS: We retrospectively analysed liver function tests and inflammatory markers of 170 admitted patients with confirmed COVID-19 in the tertiary care centre, Post Graduate Institute of Medical Education and Research (PGIMER), India, using Roche Cobas Autoanalyzer. RESULTS: Number of patients with normal liver enzyme levels were 63 (41.5%), while with raised levels of any of the liver enzymes were 89 (58.5%), out of which 43 (48.31%) had liver injury which manifested as increased severity in terms of intensive care unit (ICU) requirement (p=0.0005). Significantly raised levels of liver enzymes and liver injury were observed with age (p<0.0001) and in males (p=0.004). Significantly decreased levels of albumin and total proteins and increased levels of total bilirubin (p<0.0001) were seen in patients with abnormal liver enzyme levels and liver injury as compared to patients with normal levels. Significant increase in the levels of alanine transaminase and gamma-glutamyl transferase was seen on the 7th day, CRP and ferritin (p<0.0001) peaks were observed on 2nd and 3rd day respectively. A significant positive correlation was found between the levels of these inflammatory markers and liver function parameters. CONCLUSIONS: More than half of patients admitted to the hospital with SARS-CoV-2 infection had an abnormal liver function which was found to be associated with raised levels of inflammatory markers. Significantly higher proportions of patients with abnormal liver function were elderly and males and were at higher risk of progressing to severe disease.

Spectrum of Endocrine Dysfunction and Association With Disease Severity in Patients With COVID-19: Insights From a Cross-Sectional, Observational Study.

Introduction: Evidence on new-onset endocrine dysfunction and identifying whether the degree of this dysfunction is associated with the severity of disease in patients with COVID-19 is scarce. Patients and Methods: Consecutive patients enrolled at PGIMER Chandigarh were stratified on the basis of disease severity as group I (moderate-to-severe disease including oxygen saturation <94% on room air or those with comorbidities) (n= 35) and group II (mild disease, with oxygen saturation >94% and without comorbidities) (n=49). Hypothalamo-pituitary-adrenal, thyroid, gonadal axes, and lactotroph function were evaluated. Inflammatory and cell-injury markers were also analysed. Results: Patients in group I had higher prevalence of hypocortisolism (38.5 vs 6.8%, p=0.012), lower ACTH (16.3 vs 32.1pg/ml, p=0.234) and DHEAS (86.29 vs 117.8µg/dl, p= 0.086) as compared to group II. Low T3 syndrome was a universal finding, irrespective of disease severity. Sick euthyroid syndrome (apart from low T3 syndrome) (80.9 vs 73.1%, p= 0.046) and atypical thyroiditis (low T3, high T4, low or normal TSH) (14.3 vs 2.4%, p= 0.046) were more frequent in group I than group II. Male hypogonadism was also more prevalent in group I (75.6% vs 20.6%, p=0.006) than group II, with higher prevalence of both secondary (56.8 vs 15.3%, p=0.006) and primary (18.8 vs 5.3%, p=0.006) hypogonadism. Hyperprolactinemia was observed in 42.4% of patients without significant difference between both groups. Conclusion: COVID-19 can involve multiple endocrine organs and axes, with a greater prevalence and degree of endocrine dysfunction in those with more severe disease.

Correction to: Combined Analysis of Anti SARS-CoV-2 IgG and IgM Responses in COVID19 Patients in India.

[This corrects the article DOI: 10.1007/s12291-021-00986-x.].

Combined Analysis of Anti SARS-CoV-2 IgG and IgM Responses in COVID19 Patients in India.

Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a global health problem, India being the second most affected country. The kinetics of antibody response to SARS-CoV-2 in Indian population is not studied yet. To understand serological response in relation to age, gender, time period and severity of disease, Roche Elecsys anti-SARS-CoV-2 test was used which analysed both IgM and IgG. One hundred and three COVID-19 patients were enrolled. Seropositivity was seen in 64% of patients, with 33% at ≤ 7 days, 62% between 8 and 15 days and 81% at ≥ 16 days from the time of admission. Men (65%) showed higher antibody response than women (59%), whereas no difference was observed in seropositivity with respect to age of the patients. Dynamics of antibody responses revealed individual variations. Patients in ICU had higher antibody reactivity with 67% positivity as compared to 60% positivity in non-ICU patients. Kinetics of antibody response during COVID-19 disease varied in relation to gender, age, time period and severity and these factors might play an important role in treatment and control of COVID-19.

Demographic & clinical profile of patients with COVID-19 at a tertiary care hospital in north India.

BACKGROUND & OBJECTIVES: The COVID-19 pandemic emerged as a major public health emergency affecting the healthcare services all over the world. It is essential to analyze the epidemiological and clinical characteristics of patients with COVID-19 in different parts of our country. This study highlights clinical experience in managing patients with COVID-19 at a tertiary care centre in northern India. METHODS: Clinical characteristics and outcomes of consecutive adults patients admitted to a tertiary care hospital at Chandigarh, India, from April 1 to May 25, 2020 were studied. The diagnosis of SARS-CoV-2 infection was confirmed by real-time reverse transcriptase polymerase chain reaction (RT-PCR) on throat and/or nasopharyngeal swabs. All patients were managed according to the institute's consensus protocol and in accordance with Indian Council of Medical Research guidelines. RESULTS: During the study period, 114 patients with SARS-CoV-2 infection were admitted. The history of contact with COVID-19-affected individuals was available in 75 (65.8%) patients. The median age of the patients was 33.5 yr (13-79 yr), and there were 66 (58%) males. Of the total enrolled patients, 48 (42%) were symptomatic. The common presenting complaints were fever (37, 77%), cough (26, 54%) and shortness of breath (10, 20.8%). Nineteen (17%) patients had hypoxia (SpO2<94%) at presentation and 36 (31%) had tachypnoea (RR >24). Thirty four (29.8%) patients had an accompanying comorbid illness. Age more than 60 yr and presence of diabetes and hypertension were significantly associated with severe COVID-19 disease. Admission to the intensive care unit (ICU) was needed in 18 patients (52%), with three (2.6%) patients requiring assisted ventilation. Mortality of 2.6 per cent (3 patients) was observed. INTERPRETATION & CONCLUSIONS: Majority of the patients with COVID-19 infection presenting to our hospital were young and asymptomatic. Fever was noted only in three-fourth of the patients and respiratory symptoms in half of them. Patients with comorbidities were more vulnerable to complications. Triaged classification of patients and protocol-based treatment resulted in good outcomes and low case fatality.