Correlation between initial serum 25-hydroxyvitamin D and granulation growth in diabetic foot ulcers.

OBJECTIVE: To determine the correlation between initial serum 25-hydroxyvitamin D (25(OH)D) levels with granulation growth in diabetic foot ulcers (DFUs) after 21 days of treatment. METHOD: This cohort study involved patients with type 2 diabetes who had a DFU treated at hospital. Blood samples were taken from patients on admission. The chemiluminescent immunoassay technique was used to measure 25(OH)D levels. Granulation tissue growth was analysed by comparing the photographs from the initial treatment to day 21 of treatment. RESULTS: The median value of 25(OH)D levels at initial treatment was 8 ng/ml. The result showed no correlation between 25(OH)D levels and the granulation growth in DFUs (p=0.86). CONCLUSION: The initial serum 25(OH)D level was not correlated with the growth of granulation tissue in DFUs.

Barriers to the Use of Insulin Therapy and Potential Solutions: A Narrative Review of Perspectives from the Asia-Pacific Region.

The rising prevalence of type 2 diabetes (T2D) is posing major challenges for the healthcare systems of many countries, particularly in the Asia-Pacific Region, in which T2D can present at younger ages and lower body mass index when compared with Western nations. There is an important role for insulin therapy in the management of T2D in these nations, but available evidence suggests that insulin is under-utilized and often delayed, to the detriment of patient prognosis. The authors of this article gathered as an advisory panel (representative of some of the larger Asia-Pacific nations) to identify their local barriers to insulin use in T2D, and to discuss ways in which to address these barriers, with their outputs summarized herein. Many of the key barriers identified are well-documented issues of global significance, including a lack of healthcare resources or of an integrated structure, insufficient patient education, and patient misconceptions about insulin therapy. Barriers identified as more innate to Asian countries included local inabilities of patients to afford or gain access to insulin therapy, a tendency for some patients to be more influenced by social media and local traditions than by the medical profession, and a willingness to switch care providers and seek alternative therapies. Strategies to address some of these barriers are provided, with hypothetical illustrative case histories.

Autologous intraarterial pancreatic bone-marrow mononuclear cells infusion in T2D patients: Changes on beta-cells function, insulin resistance, and inflammatory marker.

BACKGROUND: Type 2 diabetes (T2D) is a progressive disease. Many drugs currently being used for the management of T2D have minimal effect on pancreatic beta cells regeneration. Cell-based therapies might provide potential benefits in this aspect. METHODS: A pilot study in five T2D patients with 12 months follow-up was performed to evaluate the effect of autologous bone marrow mononuclear stem cells (BM-MNCs) infusion into pancreatic arteries on the insulin requirement, beta-cell function, insulin resistance, and systemic inflammatory marker (CRP). RESULTS: The primary endpoint, a 50 % reduction of total insulin doses from baseline, was not achieved in this study. However, a trend of increasing fasting C-peptide (p = 0.07) and C-peptide 60' (p = 0.07) and 90' (p = 0.07) after a mixed-meal tolerance test was observed 12 months post-infusion compared to baseline levels. A similar result was observed for the homeostatic model assessment of beta cell function (HOMA1-B), an index for beta cell function. No improvement was observed for insulin resistance measured by homeostasis model assessment of insulin resistance (HOMA1-IR) and systemic inflammatory parameter. CONCLUSION: Intraarterial pancreatic autologous BM-MNCs infusion might potentially improve beta cell function in T2D patients, although further study is needed to confirm this finding.

Risk factors of severe hypoglycemia among patients with type 2 diabetes mellitus in outpatient clinic of tertiary hospital in Indonesia.

This study aimed to describe risk factors of severe hypoglycemia in type 2 diabetes mellitus (T2DM) patients in a tertiary care hospital in Indonesia. This study was a retrospective cohort study in the Endocrinology Outpatient Clinic of Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia. All subjects more than 18 years old who had been visiting the clinic for at least a year were included. Subjects were interviewed whether they had any severe hypoglycemia events within the past year, while data on risk factor variables of severe hypoglycemia was taken from medical records one year before data collection. We recruited 291 subjects, among whom 25.4% suffered at least one episode of severe hypoglycemia within one year. History of severe hypoglycemia (OR 5.864, p ≤ 0.001), eGFR less than 60 mL/min/1.73m2 (OR 1.976, p = 0.028), and insulin use (OR 2.257, p = 0.021) were associated with increased risk of severe hypoglycemia. In conclusion, history of previous severe hypoglycemia, eGFR less than 60 mL/min/1.73m2, and insulin use were associated with severe hypoglycemia.

Vitamin D supplementation alleviates insulin resistance in prediabetic rats by modifying IRS-1 and PPARγ/NF-κB expressions.

Background: Prediabetes is a condition of intermediate hyperglycemia that may progress to type 2 diabetes. Vitamin D deficiency has been frequently linked to insulin resistance and diabetes. The study aimed to investigate the role of D supplementation and its possible mechanism of action on insulin resistance in prediabetic rats. Method: The study was conducted on 24 male Wistar rats that were randomly divided into 6 rats as healthy controls and 18 prediabetic rats. Prediabetic rats were induced with a high-fat and high-glucose diet (HFD-G) combined with a low dose of streptozotocin. Rats with the prediabetic condition were then randomized into three groups of 12-week treatment: one group that received no treatment, one that received vitamin D3 at 100 IU/kg BW, and one group that received vitamin D3 at 1000 IU/kg BW. The high-fat and high-glucose diets were continuously given throughout the twelve weeks of treatment. At the end of the supplementation period, glucose control parameters, inflammatory markers, and the expressions of IRS1, PPARγ, NF-κB, and IRS1 were measured. Results: Vitamin D3 dose-dependently improves glucose control parameters, as shown by the reduction of fasting blood glucose (FBG), oral glucose tolerance test (OGTT), glycated albumin, insulin levels, and markers of insulin resistance (HOMA-IR). Upon histological analysis, vitamin D supplementation resulted in a reduction of the islet of Langerhans degeneration. Vitamin D also enhanced the ratio of IL-6/IL-10, reduced IRS1 phosphorylation at Ser307, increased expression of PPAR gamma, and reduced phosphorylation of NF-KB p65 at Ser536. Conclusion: Vitamin D supplementation reduces insulin resistance in prediabetic rats. The reduction might be due to the effects of vitamin D on IRS, PPARγ, and NF-κB expression.

Defining the optimum HOMA-IR cut-off value for insulin resistance among ARV-treated HIV patients in Indonesia.

BACKGROUND AND AIMS: HIV-infected patients who are treated with anti-retroviral (ARV) drugs are prone to develop insulin resistance. This study aims to determine the cut-off value of HOMA-IR score in ARV-treated HIV patients in Indonesia. METHODS: A cross-sectional study was conducted among 234 adults with HIV who received ARV therapy in HIV Integrated Care Unit of Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia. The duration of HIV diagnosis, duration of ARV therapy, metabolic syndrome status, and calculated HOMA-IR were obtained in this study. HOMA-IR cut-off point was calculated using ROC curve analysis, along with the specificity, sensitivity and likelihood ratio (LR). RESULTS: Among 234 subjects, 58% of subjects were on second-line ARV therapy. The prevalence of metabolic syndrome was 23.9%. The obtained HOMA-IR cut-off value was 2.705 with sensitivity and specificity approaching 70%, PPV 40.9%, NPV 87.6%, with positive LR of 2.15 and negative LR of 0.48. The insulin resistance prediction from the obtained HOMA-IR cut-off value was at moderate strength. Based on this cut-off value, 39.7% of the subjects experienced insulin resistance. CONCLUSIONS: Using the new proposed HOMA-IR cut-off point for HIV patient in Indonesia, the prevalence of insulin resistance among HIV-infected patients treated with ARV in Indonesia using optimum HOMA-IR cut-off value of 2.705 was 39.7%.

A Mixed Gonadal Dysgenesis in an 19 Year Old Girl with Ambigous Genitalia: A Case Report.

A 19-year-old girl was referred with delayed puberty and ambiguous genitalia. She had short stature with high blood pressure and Turner's stigmata with external genitalia Prader Score 4. Ultrasound revealed hypoplastic uterus with no gonad. Follicle stimulating hormone, luteinizing hormone and testosterone level were increased (51.29 mIU/mL, 23.66 mIU/mL and 742 ng/dl). Karyotyping revealed 46 XY with Fluorescence in situ hybridization cytogenetic study based on 300 cells showed mosaic chromosome, monosomy X (17%) and XY (83%). Laparascopic gonadectomy was done and showed that testes were only in the right inguinal canal. Then patient had external genitalia reconstruction and received estrogen replacement therapy.

Expert Opinion on Diabetes Management Challenges and Role of Basal Insulin/GLP-1 RA Fixed-Ratio Combination in People with Type 2 Diabetes from Indonesia.

Indonesia is struggling with a rapidly growing burden of diabetes due to rapid socioeconomic transition. People with type 2 diabetes mellitus (T2DM) need appropriate treatment strategies to maintain glycemic control. New modalities with simplicity, such as fixed-ratio combination of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA), further referred to as FRC, have proven to be an effective and practical therapeutic approach that may address this issue. In January 2021, a scientific expert meeting was held with the participation of endocrinologists from Indonesia to provide expert opinions regarding the optimal practical use of the FRC basal insulin/GLP1-RA. Topics discussed in the meeting included the challenges in diabetes management, clinical inertia with insulin therapy, local and international guideline positioning, initiation, titration, and switching of basal insulin and GLP-1 RA, including FRC, and the management of T2DM.

Challenges in the diagnosis of insulin resistance: Focusing on the role of HOMA-IR and Tryglyceride/glucose index.

BACKGROUND AND AIMS: Metabolic Syndrome (MS) prevalence is increasing worldwide in line with the growing prevalence of obesity. The underlying mechanism of MS is insulin resistance which can be diagnosed by measuring Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and Triglyceride/Glucose (TyG) Index. This review will focus on comparing studies assessing the HOMA-IR and TyG index cut-off points. METHODS: We carried out a comprehensive review of the literature using suitable keywords on the search engines of PubMed, Scopus, Research Gate, and Google Scholar in the month of October 2020. RESULTS: There is a high degree of variability in determining threshold levels of HOMA-IR for defining insulin resistance. The distribution of the HOMA-IR varies according to the demographic characteristics of the subjects, such as age, sex, and race, making it difficult to estimate the optimal cut-off point. Another simpler method without requiring the use of insulin assays is TyG Index. Similar to HOMA-IR, the TyG Index cut-off point from existing data shows varying results. CONCLUSION: The HOMA-IR and the TyG index are simple and widely used methods for determining insulin resistance. However, an issue that arises is determining the insulin resistance cut-off point for both methods. Further studies are needed to assess the cut-off point of insulin resistance for various ethnicities associated with the risk of developing MS later in life.

Diagnostic accuracy of palpation versus ultrasound-guided fine needle aspiration biopsy for diagnosis of malignancy in thyroid nodules: a systematic review and meta-analysis.

Thyroid nodule is a common health problem in endocrinology. Thyroid fine-needle aspiration biopsy (FNAB) cytology performed by palpation guided FNAB (PGFNAB) and ultrasound-guided FNAB (USGFNAB) are the preferred examinations for the diagnosis of thyroid cancer and part of the integration of the current thyroid nodule assessment. Although studies have shown USGFNAB to be more accurate than PGFNAB, inconsistencies from several studies and clinical guidelines still exist.The purpose of this study is to compare the diagnostic accuracy of Palpation versus Ultrasound-Guided Fine Needle Aspiration Biopsy in diagnosing malignancy of thyroid nodules.The systematic review and meta-analysis were prepared based on the PRISMA standards. Literature searches were carried out on three online databases (Pubmed/MEDLINE, Embase, and Proquest) and grey literatures. Data extraction was carried out manually from various studies that met the eligibility, followed by analysis to obtain pooled data on sensitivity, specificity, Diagnostic Odds Ratio (DOR) and Area Under Curve (AUC), and the comparison of the two methods.Total of 2517 articles were obtained, with 11 studies were included in this systematic review. The total sample was 2382, including 1128 subjects using PGFNAB and 1254 subjects using USGFNAB. The risk of bias was assessed using QUADAS-2 with mild-moderate results. The results of sensitivity, specificity, AUC and DOR in diagnosing thyroid nodules using PGFNAB were 76% (95% CI, 49-89%), 77% (95% CI, 56-95%), 0.827 and 11.6 (95% CI, 6-21) respectively. The results of sensitivity, specificity, AUC and DOR in diagnosing thyroid nodules using USGFNAB were 90% (95% CI, 81-95%), 80% (95% CI, 66-89%), 0.92 and 40 (95% CI, 23-69), respectively the results of the comparison test between PGFNAB and USGFNAB; Tsens USGFNAB of 0.99 (p = 0.023), AUC difference test of 0.093 (p = 0.000023).The diagnostic accuracy of USGFNAB is higher than PGFNAB in diagnosing malignancy of thyroid nodules. If it is accessible, the author recommends using USGFNAB as a diagnostic tool for thyroid nodules.

Hematological indices and their correlation with glucose control parameters in a prediabetic rat model.

Background and Aim: Chronic hyperglycemia in prediabetic individuals would progress to diabetes and lead to several systemic disruptions, including hematological parameters. This study aimed to investigate the correlation between prediabetes and hematological indices in a prediabetic rat model. Materials and Methods: Eighteen male rats were randomly divided into two groups of nine. Prediabetes was induced in nine rats by a 3-week high-fat and high-glucose diet, followed by low-dose streptozotocin (STZ) injection (30 mg/kg body weight). The oral glucose tolerance test was performed, and the fasting blood glucose (FBG) and insulin levels were measured 72 h after STZ administration. The control group of nine rats was given standard diets. At the end of the 3rd week, the animals fasted overnight before blood collection. Blood samples were drawn and used for the analysis of the FBG and fasting insulin levels and glycated albumin to define prediabetes criteria before hematology analysis. Results: We found a significant increase in the FBG and insulin levels in the prediabetic versus the control group. There were decreases in red blood cells, hemoglobin, and hematocrit levels and red cell distribution in prediabetic rats versus the control. At the same time, a significant increase in the platelet count was observed in the prediabetic group. There was a positive correlation between FBG and lymphocytes and neutrophil-lymphocyte ratio in prediabetic rats. On the other hand, we found a negative correlation between white blood cell count and glycated albumin. Conclusion: Correlations were found in several hematological parameters in the prediabetic rat models. The changes in hematological indices in prediabetic rats may be further used as a valuable indicator of glycemic control.

Thyroid Abscess as a Clinical Manifestation of Papillary Thyroid Carcinoma.

Even in immunocompromised patients, thyroid abscess is a rare occurrence. One factor that predisposes the thyroid gland to infection is pre-existing diseases such as thyroid nodule or thyroid cancer. A mass usually accompanies thyroid cancer. On the other hand, thyroid cancer is uncommon to present with a thyroid cyst or abscess, even as infection symptoms. In this article, we presented a 50-year-old woman who suffered from a thyroid abscess. She had been diagnosed with an untreated thyroid nodule a year prior and presenting with an enlarged, painful, and warm neck mass accompanied with fever, and dysphagia for 7 days. Treatment began with intravenous antibiotic and percutaneous drainage with intracavitary antibiotic injection. The culture contained no organism. Isthmolobectomy was performed due to expanding abscess to the surrounding tissue, and the histopathology examination confirmed thyroid abscess with a follicular variant of papillary thyroid carcinoma.

Characteristics of Diabetic Foot Ulcer Patients Pre- and During COVID-19 Pandemic: Lessons Learnt From a National Referral Hospital in Indonesia.

BACKGROUND: Diabetic foot ulcer (DFU) is one of the most terrifying diabetic complications for patients, due to the high mortality rate and risk for amputation. During the COVID-19 pandemic, many diabetic patients limited their visits to the hospital, resulting in delays for treatment especially in emergency cases. OBJECTIVE: This study aimed to compare the characteristics of patients with DFU pre- and during COVID-19 pandemic period. Methods: This study was a retrospective cohort study using foot registry data. We compared our patients' characteristics pre-COVID-19 pandemic period (1 March 2019-28 February 2020) and during COVID-19 pandemic period (1 March 2020-28 February 2021). RESULTS: Cohorts of 84 and 71 patients with DFU pre- and during COVID-19 pandemic period, respectively, were included in this study. High infection grade (66.7% vs 83.1%, P = .032), osteomyelitis event (72.6% vs 87.3%, P = .04), leukocyte count (15 565.0/µL vs 20 280.0/µL, P = .002), neutrophil-to-lymphocyte ratio (7.7 vs 12.1, P = .008), waiting time-to-surgery (39.0 h vs 78.5 h, P = .034), and number of major amputation (20.2% vs 39.4%, P = .014) were significantly higher during the COVID-19 pandemic period. CONCLUSION: During the COVID-19 pandemic, patients with DFU had more severe infection, higher proportion of osteomyelitis, longer waiting time for getting surgical intervention, and higher incidence of major amputation.

Factors Affecting Mortality of Critical Limb Ischemia 1 Year after Endovascular Revascularization in Patients with Type 2 Diabetes Mellitus.

BACKGROUND: Chronic limb ischemia (CLI) is strongly associated with increased mortality in diabetes patients. OBJECTIVE: The aim of this study was to evaluate factors affecting mortality within 1 year after endovascular revascularization in CLI patients. METHODS: This retrospective cohort study was based on medical records from the Integrated Cardiovascular Centre of Dr. Cipto Mangunkusumo National General Hospital, a tertiary care hospital in Jakarta, Indonesia. The study included 199 CLI patients with type 2 diabetes mellitus (T2DM) who underwent endovascular revascularization from January 2008 to June 2018. The patients were followed up for 1 year after endovascular revascularization. Kaplan-Meier and Cox proportional hazard analysis was used to analyze the data. RESULTS: 1-year survival probability was 58.8%. Cox proportional hazard analysis showed that duration of diabetes (HR 3.52; 95% CI 1.34-9.22), anemia (HR 2.59; 95% CI 1.47-4.56), and smoking (HR 2.49; 95% CI 1.46-4.27) were significantly associated with mortality within 1 year after endovascular revascularization. CONCLUSIONS: In T2DM patients with CLI, duration of diabetes, anemia and smoking were associated with a higher risk of mortality within 1 year post endovascular revascularization.

Effects of Sambiloto (Andrographis paniculata) on GLP-1 and DPP-4 Concentrations between Normal and Prediabetic Subjects: A Crossover Study.

BACKGROUND: The extract of Andrographis paniculata (Burm. F.) Wall. Ex. Nees. (sambiloto) ( chuan xin lián) has been reported to have an antidiabetic effect on mice models and has been used traditionally in the community. The exact mechanism of sambiloto extract in decreasing plasma glucose is unclear, so we investigated the role of sambiloto extract in the incretin pathway in healthy and prediabetic subjects. METHODS: This study was a randomized, placebo-controlled, crossover, double-blind trial. It included 38 people who were healthy and 35 people who had prediabetes. All subjects were randomly assigned to receive either the intervention sambiloto extract or a placebo. All subjects were randomly assigned to receive the first intervention for 14 days. There was a washout period between subsequent interventions. The primary outcome was glucagon-like peptide 1 (GLP-1) concentration, and secondary outcomes were fasting insulin, 2-hour postprandial insulin, homeostasis model assessment of insulin resistance (HOMA-IR), fasting blood glucose, 2-hour postprandial blood glucose, dipeptidyl peptidase-4 (DPP-4), and glycated albumin before and after the intervention. RESULT: After the intervention, GLP-1 concentration significantly increased in prediabetes by 19.6% compared to the placebo (p=0.043). There were no significant differences in the changes of fasting insulin, 2-hour postprandial insulin, HOMA-IR, fasting blood glucose, 2-hour postprandial blood glucose, DPP-4, and glycated albumin levels after the intervention. Sambiloto extract did not inhibit the DPP-4 enzyme in healthy and prediabetic subjects. CONCLUSION: Sambiloto extract increased GLP-1 concentration without inhibiting the DPP-4 enzyme in prediabetic subjects. This trial is registered with ClinicalTrials.gov (ID: NCT03455049), registered on 6 March 2018-retrospectively registered (https://clinicaltrials.gov/ct2/show/NCT03455049).

Clinicopathological Profile of Thyroid Carcinoma in Young Patients: An Indonesian Single-Center Study.

INTRODUCTION: Thyroid cancer is the third most common cancer that occurs in children and adolescents. Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy. Although the mortality rate of thyroid malignancy in children is usually low, the disease recurrence is higher in children with more severe clinical presentation than in adults. This study aimed to determine the demographic and clinicopathological characteristics and outcome of pediatric and adolescent patients with thyroid malignancy in Indonesia. METHODS: The retrospective study included all patients diagnosed with thyroid carcinoma aged <20 years, from January 1, 2015, to December 31, 2019. Twenty-nine subjects fulfilled the inclusion and exclusion criteria. We retrieved baseline characteristics, pathology features, TSH and fT4 status, radioactive iodine therapy data, and patients' outcomes. Then, data were analyzed using the chi-square or Fisher's exact method. RESULTS: We identified 29 eligible subjects, including 3 boys and 26 girls. The most common type of thyroid carcinoma was PTC (96.5%), and follicular type (31%) was the predominant variant of PTC. Lymph node involvement occurred in 24% of patients, while distant metastasis occurred in 17.2% of patients with PTC. Twenty-four (82.7%) patients had stage 1 disease. Disease recurrence was recorded in 31% of patients during the study period with a median follow-up time of 24 months. CONCLUSION: PTC is the most frequent type of thyroid carcinoma among children and adolescents. This malignancy has a low mortality rate, but the recurrence rate remains high among younger patients than adults even during a short-term follow-up analysis. Distant metastasis and lymph node involvement are commonly found in this age group.

Giant Recurrence Pituitary Adenoma After Three Times Transphenoidal Removal Surgery, One Craniotomy Procedure, and 30 Doses of External Radiotherapy.

This is a case of 42nd year-old woman with history of sight loss in her both eyes. She experienced headache and visual field decrease gradually since 2014. After several laboratory and imaging examinations, from her dynamic pituitary magnetic resonance imaging (MRI), it is concluded that she had a giant adenoma of the pituitary gland which compressed to her optic chiasm. From her pituitary laboratory hormone panel, it is revealed that the tumor is a non-functioning pituitary adenoma. From the neuro-ophthalmology (campimetry) examinations, she had papillae atrophy in her both eyes and also bilateral temporal hemianopia.

Non-vascular contributing factors of diabetic foot ulcer severity in national referral hospital of Indonesia.

PURPOSE: Diabetic foot ulcer (DFU) is a common chronic complication of type 2 diabetes mellitus (T2DM) in Indonesia, with a prevalence of 7.3%. However, the characteristics of these patients remain unclear. We investigated the characteristics of patients with DFU without peripheral arterial disease (PAD) and analyzed non-vascular factors related to severity of DFU in a tertiary care national referral hospital in Indonesia. METHODS: This was a cross-sectional study including 123 hemodynamically stable DFU patients without PAD recruited from Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia from 2010-2015. RESULTS: DFU patients were predominantly over 50 years old (75.6%) and diagnosed with T2DM for 5 years with poor glycemic control (82.7%) and peripheral neuropathy (91.3%). Most patients had anemia (86.7%), leukocytosis (84.6%), and were undernourished, as characterized by a low lipid profile (90.8%) and hypoalbuminemia (83.7%). Most had extensive size of ulcer at the initial visit, with a median size of 16.23 (2.92-60.16) cm2. Ulcers were mostly located of the forefoot (62.5%) and were caused by mechanical trauma (46.2%). Bivariate analysis revealed that significant factors for the development of DFU were related to DFU size, including duration of T2DM (p = 0.04), leukocyte levels (p = < 0.01), and thrombocyte levels (p = < 0.01). Multivariate analysis showed leucocyte (p = 0.03) and thrombocyte (p = 0.023) had significantly correlated with DFU severity. CONCLUSION: Leucocyte and thrombocyte may be the greatest contributing non-vascular factors for severity of DFU in Indonesia.

Gastroesophageal Reflux Disease among Elderly Type 2 Diabetes Mellitus in a Rural Area of Central Sulawesi: A Cross-sectional Study.

BACKGROUND: type 2 diabetes mellitus (T2DM) and gastroesophageal reflux disease (GERD) are commonly seen in the geriatric population. This study aimed to investigate the prevalence, risk factors, and alarm-symptoms incidence of GERD among elderly patients with T2DM in a rural area of Central Sulawesi. METHODS: this cross-sectional study was conducted from July-September 2019 in Public Health Center of Beteleme, Central Sulawesi. Patients aged ≥60 years old, newly or previously diagnosed with T2DM according to the 2019 American Diabetes Association (ADA) criteria or to the 2015 Indonesian Society of Endocrinology (PERKENI) criteria, were consecutively recruited. We excluded patients being on proton-pump inhibitor or H2-receptor antagonist therapy or having a history of gastric or esophageal surgery. GERD was diagnosed in patients with the score of ≥8 based on the Indonesian version of GERD questionnaire (GERD-Q). RESULTS: among 60 elders with T2DM, 28.3% (95% confidence interval [CI], 16.9-39.7) had GERD. Statistical analysis showed that GERD was significantly associated with consumption frequency of tea (p=0.019) and coffee (p=0.015). No significant relationship was found between gender (p=0.562), obesity (p=0.803), achievement of blood glucose-level control (p=0.478), duration of T2DM (p=0.304), and type of antihyperglycemic drugs (p=0.202) with GERD. Unintentional weight loss was the leading alarm symptom (47.1%; 95%CI, 23.4%-70.8%) found across the GERD group. CONCLUSION: GERD was prevalent among elderly patients with diabetes. Frequent consumption of either tea or coffee was associated with GERD. Alarm symptoms need further evaluation to screen for complications.

Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes.

PURPOSE: To compare the immunogenicity and efficacy of insulin glargine biosimilar Ezelin (EZL) versus originator insulin glargine Lantus (LAN) as a reference basal insulin in patients with type 2 diabetes (T2D). PATIENTS AND METHODS: This was a randomized, multicenter, open-label, 24-week study in insulin-naïve patients with T2D, with HbA1c of >7.0%. We randomly assigned 133 eligible patients to receive either EZL or LAN. Baseline characteristics, including insulin autoantibody (IAA), zinc transporter 8 (ZnT8) antibody, HbA1C, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPPG), AST, ALT, BUN, eGFR, and oral antidiabetic drugs, were obtained before starting insulin treatment. After starting treatment, insulin dose was titrated to achieve FPG target along with oral antidiabetic drugs. Patients were given home glucometer and assisted to record plasma glucose measurement and adverse event (AE). Every month, patients came to the diabetes clinic and performed a regular physical examination and intensifying treatment if needed. Out of the 133 randomized patients, only 122 completed the study and can be examined for their IAA and ZnT8 after 6 months of treatment. The study was registered in clinicaltrials.gov, NCT03352674. RESULTS: There is a similar proportion of patients with changes of IAA from baseline: 1 out of 58 (1.7%) patients receiving EZL versus 1 out of 64 (1.6%) patients receiving LAN (p = 1.000). One patient in the EZL group (1.7%) versus none in the LAN group experienced a change of ZnT8 antibody from baseline. Similar glucose control in EZL versus LAN was determined by the change in HbA1c, FPG, and 2hPPG (-2.0%, -67.46 mg/dL, and -76.51 mg/dL in the EZL group versus -1.7%, -58.11 mg/dL, and -70.03 mg/dL in the LAN group). There were six events of documented hypoglycemia in the EZL group versus five events in the LAN group. No patients experienced diabetic ketoacidosis during the study. CONCLUSION: Overall, insulin glargine biosimilar EZL and originator insulin glargine LAN have shown a similar immunogenicity profile, as well as efficacy in providing glucose control and safety findings in T2D populations.