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Diabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial. This parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dL) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c <7% plus BP <130/80 mm Hg and/or LDL-cholesterol <100 mg/dL) and first macrovascular endpoints (nonfatal myocardial infarction, nonfatal stroke, death, revascularization [angioplasty or coronary artery bypass graft]), which were co-primary outcomes. We also examined secondary outcomes, namely, single risk factor control, first microvascular endpoints (retinopathy, nephropathy, neuropathy), and composite first macrovascular plus microvascular events (which also included amputation and all-cause mortality) by treatment group and whether QI strategy implementation was continued over 6.5 years. At 6.5 years, assessment data were available for 854 participants (74.5%; n = 417 [intervention]; n = 437 [usual care]). In terms of sociodemographic and clinical characteristics, participants in the intervention and usual care groups were similar and participants at sites that continued were no different to participants at sites that discontinued intervention implementation. Patients in the intervention arm were more likely to exhibit sustained multiple risk factor control than usual care (relative risk: 1.77; 95% confidence interval [CI], 1.45, 2.16), p < 0.001. Cumulatively, there were 233 (40.5%) first microvascular and macrovascular events in intervention and 274 (48.0%) in usual care patients (absolute risk reduction: 7.5% [95% CI: -13.2, -1.7], p = 0.01; hazard ratio [HR] = 0.72 [95% CI: 0.61, 0.86]), p < 0.001. Patients in the intervention arm experienced lower incidence of first microvascular endpoints (HR = 0.68 [95% CI: 0.56, 0.83), p < 0.001, but there was no evidence of between-group differences in first macrovascular events. Beneficial effects on microvascular and composite vascular outcomes were observed in sites that continued, but not sites that discontinued the intervention. In urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes. ClinicalTrials.gov NCT01212328.

IntroductionEvidence on the prevalence of foot problems among people with diabetes in India at a national level is lacking. Hence, this study was aimed to assess the burden of high-risk (HR) feet in people with diabetes across India.Research design and methodsA cross-sectional national-level project ‘Save the Feet and Keep Walking’ campaign was conducted by the Research Society for the Study of Diabetes in India (RSSDI) from July 10, 2022 to August 10, 2022. A modified version of 3 min foot examination was used to assess the foot problems. Around 10 000 doctors with RSSDI membership were trained online to conduct foot screening and provided a standardised monofilament for detection of loss of protective sensation. People with diabetes aged >18 years who visited the clinics during the study period were examined for foot problems. Data were collected online using the semi-structured questionnaire. A total of 33 259 participants with complete information were included for the final analysis. The foot at risk was categorised based on International Working Group on the Diabetic Foot guidelines 2023.ResultsNearly 75% of the participants were aged above 45 years. Around 49% had diabetes duration >5 years and uncontrolled diabetes (hemoglobin A1c >8%). Presence of history of foot ulcer (20%), lower limb amputation (15.3%), foot deformities (24.5%) and absence of diminished dorsal pedis and posterior tibial pulses (26.4%) was noted in the study participants. Around 25.2% of them had HR feet and highly prevalent among males. Diabetic kidney and retinal complications were present in 70% and 75.5% of people with HR feet. Presence of heel fissures (OR (95% CI) 4.6 (4.2 to 5.1)) and callus or corns (OR (95% CI) 3.6 (3.3 to 4.0)) were significantly associated with HR feet.ConclusionsOne-fourth of people with diabetes were found to have HR feet in India. The findings are suggestive of regular screening of people with diabetes for foot problems and strengthening of primary healthcare.

Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor is effective in reducing HbA1c levels in patients with type 2 diabetes (T2DM) when administered as monotherapy, dual or triple combination therapy. In India, Vildagliptin is commonly prescribed in T2DM patients because it reduces mean amplitude of glycemic excursion (MAGE), has lower risk of hypoglycemia and is weight neutral. Early combination therapy with vildagliptin and metformin is effective and well-tolerated in patients with T2DM, regardless of age or ethnicity. In view of already existing data on vildagliptin and the latest emerging clinical evidence, a group of endocrinologists, diabetologists and cardiologists convened for an expert group meeting to discuss the role and various combinations of vildagliptin in T2DM management. This practical document aims to guide Physicians and Specialists regarding the different available strengths and formulations of vildagliptin for the initiation and intensification of T2DM therapy.

Background: Arterial Stiffness is a manifestation of endothelial dysfunction and it can be used as a prediction parameter and a target for therapies aimed at ameliorating endothelial cell dysfunction which is raised after Covid 19 infection. Aims and Objectives: To evaluate arterial stiffness using carotid-femoral Pulse Wave Velocity (cfPWV) and to compare the difference in different groups among the study subjects. Methods and Results: Observational single centre study was done after randomly selecting 170 subjects from Telangana State Police Department after excluding subjects with chronic inflammatory diseases on chronic steroid therapy and pregnant/lactating subjects. Analysis after dividing them into 4 groups based on the presence or absence of past history of COVID-19 infection and the presence or absence of Comorbidities (Diabetes Mellitus, Systemic Hypertension, CAD, CVA or CKD) showed mean increase in cfPWV was 76.21 cm/s in Group-A (Covid-ve & Comorbidity-ve), 126.5 cm/s in Group-B (Covid+ve & Comorbidity-ve), 210.1 cm/s in Group-C (Covid-ve & Comorbidity+ve) and 263.9 cm/s in Group-D (Covid+ve & Comorbidity+ve). Significant p values were obtained for intergroup differences in cfPWV. Conclusions: The Arterial stiffness values of prior COVID-19 positive subjects were higher than the group of subjects without prior COVID-19 infection. Comorbidities also independently added to the risk. Pulse wave velocity can be considered as an easy non-invasive screening tool in post-COVID patients to identify possible high-risk candidates.

Abstract Disclosure: N. Kudugunti: None. S. Bangaru: None. R.K. Sahay: None. Background: In pre-pubertal period, a major part of the testicular tissue is constituted by Sertoli cells for which AMH, Inhibin B are specific biomarkersHigh AMH, Inhibin B levels in the prepubertal period is via FSH stimulation, which is mistakenly considered to be silent due to its reduced activity Aim & Objectives: To assess AMH and Inhibin B measurements in the diagnostic workup of prepubertal children with different subtypes of 46,XY DSD and comparing with normal controls To assess Sertoli cell function with AMH and Inhibin B and to assess correlation between testosterone elevation after hCG stimulation, basal AMH and Inhibin B Patients and methods: Pilot study-Single centered, Cross-sectional Observational study. After ethical committee approval, 40 children with 46,XY DSD & 40 healthy age matched, boys as controls recruited after taking assent. All children with DSD underwent karyotyping, assessment of hCG stimulated testosterone, DHT and androstenedione. Basal AMH and inhibin B were measured in both cases and controls. Data were analysed using IBM SPSS version 25. Results: The mean age at presentation was 4.09 years.The diagnosis was made clinically and biochemically, genetic analysis done in few patients. Out of 40 cases, 26 had normal hCG stimulated testosterone of >100 ng/dl (17 cases were 5 alpha reductase type 2 deficiency [5αR2D], 9 cases were PAIS) & 14 had low hCG stimulated testosterone of <100 ng/dl (8 cases were 17βHSD3 deficiency, 4 cases were Partial gonadal dysgenesis [PGD], 2 cases were Vanishing testis syndrome). In the low testosterone group, mean AMH in 17βHSD3 deficiency-279.95 ng/ml, in PGD-31.16 ng/ml which is statistically significant in differentiating these disorders(p-0.002)& mean Inhibin B in 17βHSD3 deficiency-186.41 pg/ml, in PGD-35.95 pg/ml which is statistically significant in differentiating these disorders (p-0.007). In vanishing testis syndrome, AMH & Inhibin B were helpful in confirming the absent functioning testicular tissue Whereas in normal testosterone group, mean AMH in PAIS-235.65 ng/ml, in 5αR2D-289.08 ng/ml difference is not statistically significant(p-0.36)& mean Inhibin B in PAIS-204.50 pg/ml, in 5αR2D-190.91 pg/ml difference is not statistically significant(p-0.72) There was significant correlation between basal AMH and hCG stimulated testosterone (r=0.434; p-0.002), Inhibin B and hCG stimulated testosterone(r=0.438; p-0.001), AMH and Inhibin B(r=0.770; p<0.001). Conclusion: AMH and Inhibin B are valuable in differentiating PGD, 17βHSD3 deficiency in low hCG stimulated testosterone patients, but not helpful in differentiating PAIS, 5αR2D in normal hCG stimulated testosterone patients. Especially in PGD they may have a role with respect to fertility prospects and malignancy risk assessment. Presentation: 6/3/2024

Disclosure: R.K. Sahay: Speaker; Self; Novo Nordisk, Roche Diagnostics. S.A. Kalam: None. N. Kudugunti: Speaker; Self; Novo Nordisk. S. Togarla: None. Background: The Indian subcontinent has shown higher prevalence for both thyroid dysfunction and diabetes complicating pregnancy when compared to the Western population. The association between both has been studied in multiple small studies which have however shown discordant results. Hence the need for exploring this further. Aims: To assess the proportion of women with thyroid autoimmunity and thyroid dysfunction in pregnancy complicated by diabetes mellitus and determine association of the same with diabetes in pregnancy and maternal and perinatal outcomes. Methods: 150 pregnant women with gestational/pregestational diabetes were enrolled in this cross sectional study and the proportion of those with thyroid dysfunction were assessed. Thyroid autoimmunity was evaluated in the same population using antiTPO and anti-thyroglobulin antibodies. The proportion of women with thyroid autoimmunity as well as thyroid dysfunction was calculated and the association of these with diabetes in pregnancy was evaluated along with maternal and perinatal outcomes. The same tests were done on 26 pregnant women without diabetes who served as controls. Results: The mean age of the study population was 26.62 ± 4.34 years. 56% were diagnosed with GDM and the rest had pre-GDM. 26.6% of the study population were diagnosed with hypothyroidism. Of these,45% were newly diagnosed during the current pregnancy. The prevalence of antiTPO antibody positivity was found to be 9.33% whereas that of anti-thyroglobulin antibody was 3.33%. Maternal and perinatal complications were higher in the group with combined endocrinopathy with gestational hypertension and preterm delivery showing statistically significant increase among the latter group. Among those women with combined endocrinopathy who developed gestational hypertension,76.9% had GDM. All of them were found to have subclinical hypothyroidism which was newly diagnosed in third trimester. Conclusion: The prevalence of hypothyroidism in pregnancy complicated by diabetes is higher than the prevalence in normal pregnancy. Undiagnosed subclinical hypothyroidism was found to be strongly associated with development of gestational hypertension. Our study emphasises the fact that women with diabetes in pregnancy should receive early and periodic screening for thyroid dysfunction in pregnancy. Presentation: Thursday, June 15, 2023

Abstract Disclosure: N. Kudugunti: None. L. Sudhakaran: None. D.P. Thuli: None. S. Edigakornapalli: None. R.K. Sahay: None. Background: Thyroid hormone plays a crucial role in pregnancy, and mild TSH elevation (2.5-4 mIU/L) is commonly encountered, but its impact on pregnancy and neonatal outcomes remains unclear. The treatment practices in managing pregnant women with mild TSH elevation (2.5 - 4 mIU/L) is highly variable, especially where anti-TPO testing is not routinely available. This study aimed to evaluate whether levothyroxine treatment in pregnant women with TSH levels between 2.5 and 4 mIU/L influences pregnancy and neonatal outcomes. Methodology: This retrospective study reviewed data from women with singleton pregnancies who delivered at a tertiary care center in South India between January 2022 and December 2023. A waiver of consent was obtained due to the use of de-identified data, with the goal of evaluating pregnancy and neonatal outcomes in women with mild TSH elevation (2.5-4 mIU/L). Inclusion criteria included delivered women in the postnatal ward, and exclusion criteria included those with multiple pregnancies, missing TSH values, or pre-existing thyroid disorders. A structured proforma was used to collect data on detailed history, clinical examination, and antenatal investigations across all trimesters. Delivery and neonatal outcomes, including gestational age, mode of delivery, neonatal complications, and birth weight, were also documented. The subjects were divided into treated and untreated group and was compared to women with TSH between 0.5 and 2.5 mIU/L. Statistical analysis was done to investigate the effect of treatment on pregnancy and neonatal outcomes. Results: Among 854 pregnant women with TSH levels between 2.5 and 4 mIU/L, 408 (47.7%) received levothyroxine treatment, while 446 remained untreated. These two groups were compared to 416 women with TSH levels between 0.5 and 2.5 mIU/L. Pregnant women with TSH between 2.5 and 4 mIU/L were older and overweight/obese compared to pregnant women with TSH below 2.5 mIU/L. The incidence of anaemia was significantly higher in the group with TSH between 2.5 and 4 mIU/L. Rates of gestational diabetes and preeclampsia were not significantly different across the groups. The cesarean section rate was also comparable among the groups. Preterm birth rates (<37 weeks) did not differ significantly between the treated and untreated groups. Neonatal outcomes, including NICU admissions, were also not different across the groups. Conclusion: Treatment of pregnant women with mildly raised TSH levels did not show any significant difference in pregnancy and neonatal outcomes in this study. Presentation: Saturday, July 12, 2025

Background: The Indian subcontinent has shown higher prevalence for both thyroid dysfunction and autoimmunity as well as diabetes complicating pregnancy when compared to the Western population. Despite the potential serious implications of this problem, not enough attention has been paid in our country to understand this, and there is an urgent need to explore the same. Aims: To assess the proportion of women with thyroid autoimmunity and thyroid dysfunction in pregnancy complicated by diabetes mellitus and determine association of the same with diabetes in pregnancy and maternal and perinatal outcomes. Methods: We conducted a cross sectional study in which pregnant women with gestational as well as pregestational diabetes were enrolled and the proportion of those with thyroid dysfunction were assessed. Thyroid autoimmunity was evaluated in the same population using anti TPO and anti-thyroglobulin antibodies. The proportion of women with thyroid autoimmunity as well as thyroid dysfunction was calculated and the association of these with gestational and pregestational diabetes was evaluated. Those with thyroid autoimmunity was compared with those without autoimmunity and the association of each group with the presence of diabetes mellitus was evaluated. The same tests were done on pregnant women without diabetes or thyroid disease who served as controls. Results: The mean age of the study population was 26.62 ± 4.34 years. Among the gestational diabetics, the mean gestational age at diagnosis was 28.39 ± 4.69 weeks. The average duration of diabetes among those with pregestational diabetes was 3.10 ± 1.32 years. 40.67% participants had a family history of diabetes and 14% had family history of hypothyroidism. 56% were diagnosed with GDM and the rest had preGDM. Acanthosis nigricans was noted in 63.34% participants and 37.3% had goitre. 26.6% of the study population were diagnosed with hypothyroidism, none had hyperthyroidism. Of these, 45% were newly diagnosed during the current pregnancy.30.95% of those with GDM were noted to have hypothyroidism whereas it was 21.2% in preGDM. The prevalence of anti TPO antibody positivity was assessed in 140 patients which was found to be 9.29% whereas that of anti-thyroglobulin antibody was 3.57%.4.67% participants were noted to have oligohydramnios and 10% had polyhydramnios. 46.6% of those with polyhydramnios were found to have associated hypothyroidism which was statistically significant (P=.01). Maternal complications like gestational hypertension, pre term delivery, post-partum hemorrhage and caesarean section as well as neonatal complications like neonatal jaundice were higher in women with combined endocrinopathy. Conclusion: The prevalence of hypothyroidism in pregnancy complicated by diabetes mellitus is higher than the prevalence in normal pregnancy. About one third of those with gestational diabetes and more than one fifth of those with pregestational diabetes were found to have hypothyroidism in our study. Almost half of patients with polyhydramnios were found to have associated hypothyroidism. Maternal complications and neonatal jaundice were found to be higher among those with combined endocrinopathy. However, the prevalence of thyroid autoimmunity in our study was lower as compared to previously published data which could be because of regional differences in iodine sufficiency or other unrecognised endocrine disruptors which could be at play. Nevertheless, our study emphasises the fact that women with diabetes in pregnancy should receive early and periodic screening for thyroid dysfunction in pregnancy.