Study of Glycemic Variability in Well-controlled Type 2 Diabetic Patients Using Continuous Glucose Monitoring System.

INTRODUCTION: The world has changed tremendously for patients suffering from diabetes mellitus with the development of cutting-edge technologies like continuous glucose monitoring and flash glucose monitoring systems. Now, the details of constant fluctuations of glucose in their blood can be monitored not only by medical professionals but also by patients, and this is called glycemic variability (GV). Traditional metrics of glycemic control measurement, such as glycated hemoglobin (HbA1c), fail to reflect various short-term glycemic changes like postprandial hyperglycemia and hypoglycemic episodes, paving the way to the occurrence of various diabetic complications even in asymptomatic, well-controlled diabetic patients. This need for advanced management of diabetes and effective monitoring of these swings in blood glucose can be met by using a continuous glucose monitoring system (CGMS). AIM AND OBJECTIVE: To evaluate the extent of GV in well-controlled type 2 diabetes mellitus (T2DM) patients using a flash CGMS and to assess the correlation between GV and HbA1c. MATERIALS AND METHODS: A hospital-based prospective observational study was carried out from May 2020 to Oct 2021 at the Department of Medicine, SMS Hospital, Jaipur, Rajasthan (India), after approval from the Ethics Committee of the institution. A total of 30 patients with well-controlled T2DM (HbA1c was ≥6.5, but ≤7.5) were included in the study using simple random techniques after written informed consent from patients. Patients were studied for glycemic excursions over a period of 7 days by using FreeStyle® Libre Pro™, which is a flash glucose monitoring system. The CGM sensor was attached to the left upper arm of the patient on day 0 and removed on day 7. The data recorded in the sensor was then retrieved using pre-installed computer software and analyzed using standard CGM metrics like standard deviation (SD), percentage coefficient of variation (%CV), time above range (TAR), time below range (TBR), and time in range (TIR), out of which %CV was used to quantify GV. %CV has been used to cluster patients into four cohorts from best to worst, namely: best/low CV ≤ 10%, intermediate CV from 10 to 20%, high CV from 20 to 30%, and very high CV of >30%. Scatterplots are used to establish correlations between various parameters. RESULT: Data from a total of 30 patients were analyzed using CGMS and thus used for calculating standard CGM metrics; glucose readings every 15 minutes were recorded consecutively for 7-day periods, making it a total of 672 readings for each patient. Interpreting the CGM data of all 30 patients, the following results were found: the mean blood glucose of all cases is 134.925 ± 22.323 mg/dL, the mean SD of blood glucose of all cases is 35.348 ± 9.388 mg/dL, the mean of %CV of all cases is 26.376 ± 6.193%. CGM parameters of time are used in the form of percentages, and the following results were found: the mean of TAR, TBR, and TIR is 14.425 ± 13.211, 5.771 ± 6.808, and 82.594 ± 12.888%, respectively. Clustering the patients into cohorts, the proportion of patients exhibiting best/low %CV (10%) is 0, intermediate %CV (10-20%) is 16.67% (five out of 30 patients), high %CV (20-30%) is 50% (15 out of 30 patients) and very high %CV (>30%) is 33.33% (10 out of 30 patients). Also, there is no significant correlation found between HbA1c and %CV (ρ = 0.076, p-value = 0.690); a significant negative correlation was found between %CV and TIR (ρ = -0.604, p < 0.001S); a positive correlation of %CV with TAR and TBR is significant (ρ = 0.816, p-value of <0.001). CONCLUSION: Using a flash CGMS device and considering %CV as the parameter and primary measure of GV, the study demonstrated the overall instability of a person's glycemic control, making note of unrecognized events of hypoglycemia and hyperglycemia in asymptomatic well-controlled T2DM patients, revealing the overall volatile glycemic control. The most important finding of this study is that even those diabetics who are considered well-controlled experience a great degree of GV as assessed by CGM-derived metrics. This study also demonstrated that there is no significant correlation between HbA1c and GV, suggesting that patients may not have optimal control of their diabetes despite having "normal HbA1c" values; hence, GV can be considered an HbA1c-independent danger factor, having more harmful effects than sustained hyperglycemia in the growth of diabetic complications. So, by using CGM-derived metrics, the measurement of GV has the potential to complement HbA1c data. In this manner, a more comprehensive assessment of glycemic excursions can be provided for better treatment decisions, thereby facilitating optimal glycemic control, which is essential for reducing overall complications and promoting good quality of life.

A Study of Relationships between the HbA1c Level and Inflammatory Markers, Neutrophil-to-Lymphocyte Ratio, and Monocyte-to-Lymphocyte Ratio in Controlled and Uncontrolled Type 2 Diabetes Mellitus.

AIM AND OBJECTIVE: To assess the relationship between glycated hemoglobin (HbA1c) with inflammatory markers, neutrophil-to-lymphocytes ratio (NLR), and monocyte-to-lymphocytes ratio (MLR) in controlled and uncontrolled type 2 diabetes patients. MATERIALS AND METHODS: This was a hospital-based cross-sectional study conducted at the Department of Medicine, SMS Hospital, and an attached group of hospitals (Jaipur, Rajasthan, India) after informed consent from the Ethics Committee of the institute. After obtaining informed consent from patients who met the inclusion and exclusion criteria, 200 diabetic patients were included in the study using the simple randomization method. Following a detailed history and diagnosis, vital demographic information, and blood tests were collected from patients via a predesigned preliminary questionnaire. The following blood tests were collected: white blood cell (WBC), Hb, hematocrit (HCT), red cell distribution width (RDW), neutrophils, lymphocytes, HbA1c, blood glucose, NLR ratio, and MLR ratio. Data were entered and analyzed using Statistical Package for the Social Sciences version 22. RESULTS: The mean age of patients with controlled diabetes mellitus was 54.10 years, while that of patients with uncontrolled diabetes mellitus was 55.3 years. Glycemic control was more in the age group of 51-60 years. Around 54% of males and 46% of females were included in the present study, and no association was found between the two genders with poor and good glycemic control. Around 63.29% of participants with uncontrolled diabetes have an increased NLR, and 61.39% of participants with uncontrolled diabetes have an increased MLR. A strong association was found between the NLR and MLR with the glycemic control. CONCLUSION: Uncontrolled diabetes mellitus had a positive association with inflammatory markers, that is, NLR and MLR. STATEMENT OF SIGNIFICANCE: Diabetes mellitus is the most common metabolic disorder in Asian countries. It leads to many acute and chronic complications in uncontrolled diabetes. Markers like the NLR ratio and MLR ratio are inexpensive and easily available for blood investigation. Hence, these markers are quite useful in differentiating controlled and uncontrolled diabetes and, therefore, useful in predicting blood sugar control in type 2 diabetes mellitus.

To Estimate the Prevalence of Obesity and High Blood Pressure among Undergraduate Students at a University Medical Institution in North India.

Background: Hypertension is a major public health issue in India. Early detection and management of high blood pressure (BP) is crucial, especially among young adults. This study aimed to estimate the prevalence of obesity and hypertension among undergraduate medical students. Materials and methods: A cross-sectional study was conducted among 450 first year undergraduate medical students aged 18-25 years in S.M.S. Medical and Hospital Jaipur, Rajasthan after clearance from institutional ethics committee and written consent from participants. Anthropometric measurements like height, weight, BMI, waist circumference, hip circumference and blood pressure were recorded. Hypertension was defined as per JNC VIII guidelines. Data was analyzed using appropriate statistical tests. Results: Overall, 15.56% students were hypertensive and 40.67% were prehypertensive. Hypertension was more prevalent in males (18.83%) compared to females (12.33%) (p = 0.002). Overweight/obesity was present in 29.33% students, more common in males (37.67%) than females (21.15%) (p < 0.001). Obese students had higher rates of prehypertension (47%) and hypertension (28.8%). Abnormal waist-hip ratio and waist-stature ratio were significantly associated with hypertension (p < 0.001). Conclusion: Overweight/obesity and hypertension are highly prevalent among undergraduate medical students, especially males. Unhealthy lifestyles and risk factors need to be addressed to prevent long term morbidity. Routine screening and health promotion activities should be conducted for this high risk group. How to cite this article: Sharda K, Saxena P, Yadav SK, et al. To Estimate the Prevalence of Obesity and High Blood Pressure among Undergraduate Students at a University Medical Institution in North India. J Assoc Physicians India 2023;71(11):30-35.

Type 1 Renal Tubular Acidosis with Hypokalemic Quadriparesis in Sjogren Syndrome.

Sjogren syndrome is an autoimmune disease characterised by lymphocytic infiltration and inflammation of the exocrine glands resulting in decreased secretion of involved glands which manifests mostly as dry eye and dry mouth. The prevalence of the disease is reported to be about 10.3 per 10,000 population. It is more common in females with a male: female ratio of 16:1. Extra glandular manifestations are seen in up to 1/3rd of the cases. Renal involvement is seen in 4.9% of patients with Sjogren syndrome. MATERIAL: Here we present three cases of Sjogren Syndrome who presented to our hospital with hypokalaemic quadriparesis. OBSERVATION: On evaluation all three of the patients were found to have renal tubular acidosis type 1. None of these patients had any symptom of Sjogren syndrome before the onset of quadriparesis. All of these patients had acute onset progressive areflexic quadriparesis with involvement of facial muscles and drooping of eyelids without sensory or bladder bowel involvement. One of these patients had respiratory muscle paralysis severe enough to mandate mechanical ventilation. Arterial Blood Gas analysis and urine electrolyte analysis were suggestive of type 1 renal tubular acidosis. ANA positive in 2 of the 3 patients. Anti-SSA & anti-SSB antibodies were positive in all three patients. Supportive measures and IV fluid and electrolyte correction was done. There was complete recovery of power in all three patients and were discharged on oral medications.Renal Tubular Acidosis is characterised by inability of the nephrons to maintain physiologic acid base balance. This usually results from a defect in the tubular transport mechanisms. Distal Renal tubular acidosis (as in these patients) is further defined by an alkalotic urinary pH(>5.5) and profound hypokalemia due to impairment in H+ secretion in ditstal tubular alpha-intercalated cells. Owing to this imbalance of ionic transport in distal tubules there can be nephrocalcinosis, nephrolithiasis, rickets and severe muscle weakness. Sjogren syndrome is one of the etiologies leading to development of T1RTA.T1RTA can be the presenting feature of Sjogren Syndrome. CONCLUSION: Though a rare manifestation of the disease if can be the presenting symptom. Work up for RTA (ABG, urine electrolytes, Urine PH and osmolarity etc) in patients with hypokalaemic paresis can help establish the etiological diagnosis(ANA, anti-SSA,anti-SSB) and help prevent future relapses of the disease.

Fixed-dose Combination of Metoprolol, Telmisartan, and Chlorthalidone for Essential Hypertension in Adults with Stable Coronary Artery Disease: Phase III Study.

INTRODUCTION: The aim of the study was to evaluate the efficacy and safety of fixed-dose combination (FDC) of metoprolol, telmisartan, and chlorthalidone in patients with essential hypertension and stable coronary artery disease (CAD) who showed inadequate response to dual therapy. METHODS: In this phase III, open-label, multicenter study, 254 adults with stable CAD having uncontrolled hypertension despite being treated with FDC of metoprolol (25/50 mg) and telmisartan (40 mg) were included. Patients received either of the following FDC for 24 weeks: metoprolol (25 mg), telmisartan (40 mg), and chlorthalidone (12.5 mg) (FDC1; n = 139) or metoprolol (50 mg), telmisartan (40 mg), and chlorthalidone (12.5 mg) (FDC2; n = 115) tablets once daily. The FDCs were developed using the novel Wrap Matrix™ platform technology. Primary endpoint assessed the mean change in seated diastolic blood pressure (SeDBP) and seated systolic blood pressure (SeSBP) from baseline to 24 weeks. Secondary efficacy endpoints included proportion of patients achieving < 90 mmHg SeDBP (SeDBP responder) and < 140 mmHg SeSBP (SeSBP responder) at weeks 12, 16, 20, and 24. Safety was assessed throughout the study. RESULTS: A total of 243 (95.70%) patients completed study. The mean change in BP from baseline (FDC1, 155/96 mmHg; FDC2, 165/98 mmHg) to week 24 (FDC1, 128/82 mmHg; FDC2, 131/83 mmHg) was statistically significant (both groups p < 0.0001). Within FDC1 and FDC2, the mean change from baseline to week 24 in SeDBP (82.60 mmHg and 83.09 mmHg) and SeSBP (128.07 mmHg and 131.29 mmHg) was statistically significant (both groups p < 0.0001). At week 24, in FDC1, 80.15% and 84.73% were SeDBP and SeSBP responders, respectively; in FDC2, 79.46% and 74.11% were SeDBP and SeSBP responders, respectively. No serious adverse events or deaths were reported. CONCLUSION: Triple FDCs of metoprolol, telmisartan, and chlorthalidone were considered effective and well tolerated in patients with hypertension who respond inadequately to dual therapy. CLINICAL TRIAL REGISTRATION: CTRI/2016/11/007491.

The increasing prevalence of hypertension in India requires immediate attention. To adequately manage blood pressure and ensure compliance to medications, innovative treatment options involving combination therapy with three or more drugs to treat hypertension need to be explored. Fixed-dose combination (FDC) of three antihypertension drugs, viz., metoprolol, telmisartan, and chlorthalidone, were tested in Indian patients who could not respond adequately to dual treatment. The rationale behind using a combination of three drug types was to take advantage of the complementary actions of each drug class for an enhanced treatment effect. The two variants of FDCs were tested in 254 adults with the most common form of heart disease, i.e., stable coronary artery disease. Changes in seated diastolic and systolic blood pressure (SeDBP and SeSBP) were measured to assess the effectiveness of the FDC. The mean changes in SeDBP and SeSBP were statistically significant by the end of the study, i.e., it determined that results are not explainable by chance alone. A greater proportion of patients (range 74­84%) achieved their target BPs with the FDC used in the study. The FDC variants were well tolerated without any reports of serious adverse events or deaths. Overall, this triple combination therapy option was effective and considered safe to be administered to hypertensive Indian adults with stable coronary artery disease who did not respond adequately to dual antihypertension therapy.

Study of Association of Thyroid Hormone in Pre-Eclampsia and Normal Pregnancy.

AIM: The aim of the study was to assess association of thyroid hormone in preeclampsia and normal pregnancy. MATERIAL AND METHOD: This was a hospital based observational case control study. Total 100 women were included, out of them 50 normal pregnant women in control group and 50 pre-eclamptic women in case group were included. RESULT: In this study no significant difference was found in FT3 (p value 0.085) and FT4 (p value 0.065) in control and case group. TSH and Anti TPO levels in control and case group were statistically significant (p value <0.001 and <0.000). CONCLUSION: We observed that thyroid hormones (TSH and Anti TPO) have statistically significant relation in pre-eclamptic women.

Serum magnesium: an early predictor of course and complications of diabetes mellitus.

The aim of this study was to evaluate relationship between serum magnesium and course of diabetes mellitus and also to find out, if there is any relation between serum magnesium and various complications of diabetes mellitus. A cross-sectional study was conducted to examine the relationship between serum magnesium in 50 type 1 and type 2 diabetic patients with or without complications and 40 normal healthy persons. Serum magneisum estimation was done using calmagite dye method using autoanalyser (Beckman DU clin systems). Serum magnesium levels in diabetic population was significantly low (1.93 +/- 0.282 meq/l) in comparison to control (2.25 +/- 0.429 meq/l). It was statistically significant (+3.84; p < 0.005). Serum magnesium was significantly low in diabetes with complication than without complications (p < 0.001). Duration of diabetes and serum magnesium were inversely related. Poor glycaemic control was associated with hypomagnesaemia (-2.623; p < 0.05). There was strong association between hypomagnesaemia and retinopathy (1.76 +/- 0.26), obesity (1.878 +/- 0.326) and hypertension (1.75 +/- 0.071) and it was statistically significantly (p < 0.005, 0.042, 0.000 respectively). Hence it is concluded that the change in serum magnesium level may have a bearing on the complication and morbidity in patients of diabetes mellitus.

A randomized placebo controlled trial of Inolter (herbal product) in the treatment of type 2 diabetes.

OBJECTIVE: To evaluate the safety and effectiveness of Inolter in achieving glycemic control and changes in lipid profile of newly diagnosed type 2 diabetics. STUDY DESIGN: A randomized, placebo-controlled double blind. Sixty newly diagnosed patients of type-2 diabetes were randomized. Of these, 30 were put on Inolter monotherapy and 30 patients on placebo. Efficacy of Inolter was determined by observing glycemic control by estimating glycosylated haemoglobin (HbA1c) and fasting blood sugar (FBS), alteration of lipid profile by serum cholesterol, LDL, VLDL, HDL and triglycerides. STATISTICAL METHODS: Student's unpaired 't' test. RESULTS: Patients compliance was satisfactory and no adverse effects were observed. Better hypoglycemic effect was observed with Inolter both respect to fasting blood sugar (mean 65.4 +/- 63.72 mg/dl) compared to placebo (mean 26.45 +/- 38.3 mg/dl) (p < 0.001). The mean change, with Inolter, in serum cholesterol (21.33 +/- 26.05 mg/dl), serum triglyceride (30.36 +/- 32.62 mg/dl), VLDL (8.85 +/- 3.25 mg/dl), LDL (10.00 +/- 4.48 mg/dl) and HDL (-2.33 +/- 5.66 mg/dl) was also significantly different (p < 0.001) from those given placebo, where it was 15.7 +/- 20.14 mg/dl, 8.70 +/- 13.24, 0.10 +/- 4.10 mg/dl, -0.70 +/- 4.58 mg/dl and 0.65 +/- 0.00 mg/dl, respectively. CONCLUSION: Inolter appears to be an useful adjunctive therapy to exercise and diet control in newly diagnosed type 2 diabetes mellitus.