Uncontrolled Type 2 Diabetes Mellitus Patients Research Articles

Empagliflozin add‐on therapy is superior to metformin monotherapy in diabetic patients with NAFLD: An open‐label, single‐center, pilot clinical trial

AbstractBackgroundThe prevalence of non‐alcoholic fatty liver disease (NAFLD), which is characterized by hepatic steatosis, inflammation, and advanced fibrosis, is high among type‐2 diabetes mellitus (T2DM) patients. Empagliflozin (EMPA), a sodium‐glucose cotransporter‐2 inhibitor, has been well established to improve glycemic status in T2DM. However, evidence of the desirable effects of EMPA, when added to the standard treatment in diabetics with coexisting NAFLD, has yet to be determined.ObjectiveThe main objective of the current study is to explore the benefits of EMPA on hepatic fat content in patients with T2DM and NAFLD, who received metformin (MET) monotherapy.MethodsIn this open‐label clinical trial study, 60 patients with T2DM and NAFLD were assigned to either the MET + EMPA or MET group in an up‐titrated manner for 24 weeks. Anthropometric characteristics, blood glucose indices, lipid profile, liver enzymes, and steatosis grades were measured at baseline and 24 weeks after the intervention.ResultsThe results showed that in patients with a mean age of 53.26 ± 7.64 who received MET+ EMPA, all the parameters had a greater decrease than the MET group. In addition, the reduction of FBS, BS, HbA1C, TG, and ALT had a statistically significant difference between the two groups after 24 weeks follow‐up (p < 0.05). Notably, in the MET+ EMPA group, there was a substantial improvement in steatosis grades based on the fibroscan and ultrasound modality results.ConclusionThe EMPA add‐on therapeutic schedule in uncontrolled T2DM patients with NAFLD significantly ameliorated steatosis stages, liver function, anthropometric features, and biochemical parameters.

Association of Glycemic Control with Right Ventricular Function Assessed by Two-dimensional Speckle-tracking and Three-dimensional Echocardiography in Type 2 Diabetes Mellitus

Right ventricular (RV) involvement has been reported in type 2 diabetes mellitus (T2DM). The relationship between glycemic control and RV function remains unknown. We aimed to investigate the association between glycemic control and RV function assessed by two-dimensional speckle-tracking echocardiography (2D-STE) and three-dimensional echocardiography (3DE) in T2DM individuals. This study prospectively enrolled 207 patients with T2DM and 84 individuals with normal glucose metabolism (NGM). T2DM patients were divided into two subgroups according to glycated hemoglobin (HbA1c) level: controlled (HbA1c < 7.0%, n = 91) and uncontrolled subgroup (HbA1c ≥ 7.0%, n = 116). RV free wall longitudinal strain (RVFWLS) was acquired by 2D-STE, RV volumes and RV ejection fraction (RVEF) were assessed using 3DE. RV coupling to pulmonary circulation was defined as the ratio of RVFWLS/pulmonary artery systolic pressure (PASP). Controlled and uncontrolled T2DM subgroups had impaired RV function as reflected by reduced RVFWLS and RVEF compared to the NGM group. The reduction in RVFWLS was more pronounced in the uncontrolled subgroup than in the controlled subgroup (P < 0.001), whereas no significant difference was found in RVEF between these two T2DM subgroups. Higher PASP and lower RVFWLS/PASP ratio were also noted in uncontrolled T2DM patients. Additionally, the incidence of RV dysfunction was significantly higher in the uncontrolled T2DM patients than in the controlled subgroup (43.1% vs 17.6%, P < 0.001). After adjustment for potential clinical confounders, PASP and left ventricular parameters, HbA1c level was independently associated with RVFWLS (β = 0.290, P = 0.003) and RVFWLS/PASP ratio (β = 0.028, P = 0.006). Subclinical RV myocardial dysfunction is present in T2DM patients and is more pronounced in patients with uncontrolled blood glucose. HbA1c level is independently associated with subclinical RV myocardial dysfunction, providing further insight into a possible link between poor glycemic control and diabetic cardiomyopathy.

Improvement in Glycemic Indices and Point in Range by Addition or Switch to IDegAsp–Real-World Evidence

Abstract Aim and Objectives: This study aimed to evaluate the effectiveness of insulin degludec/insulin aspart (IDegAsp) in uncontrolled type 2 diabetes mellitus (T2DM) patients in clinical practice settings. Materials and Methods: This study includes a retrospective analysis of uncontrolled T2DM patients on oral antidiabetic drugs and/or insulin (basal, bolus, or premix) and initiated on IDegAsp and in a subgroup of patients who switched from insulin glargine to IDegAsp. Clinical endpoints were mean change in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and % point in range (PIR) before and after treatment with IDegAsp. Descriptive statistics were applied to analyze the data, and statistical significance was set at P ≤ 0.05. Results: A total of 540 patients with T2DM were initiated on IDegAsp, among which 85 switched from insulin glargine (U100/300) to IDegAsp. In 6 months, overall, the mean change in glycemic variables HbA1c, FPG, and PPG was –0.3%, –21 mg/dL, and –36 mg/dL, and among those who switched from insulin glargine to IDegAsp, it was –0.4%, –18 mg/dL, and –49 mg/dL, respectively, and the difference was statistically significant (P &lt; 0.05). Self-monitored blood glucose, 1 month before and from 4 to 6 months after initiation of IDegAsp was assessed in overall 43 patients. The % PIR before breakfast and before dinner (BBF+BD) was 68% and 69% (95% CI –4.413 to 4.902) respectively. Furthermore, among those who switched from insulin glargine to IDegAsp (n = 25), BBF + BD increased from 67% to 77% (95% CI –10.35 to 10.65). Conclusion: Our results show clinically significant improvements in glycemic variables and PIR in patients treated with IDegAsp and especially in patients who switched from insulin glargine (U100/300) to IDegAsp.

Preferences and Prescription Practices for Managing Diabetes with a Special Reference to the Clinical Use of Sitagliptin in Indian Settings

Background: Although there were several clinical studies regarding the effectiveness of sitagliptin, there were dearth of studies on the prescription patterns and practices among clinicians. Methodology: This cross-sectional study included 19 statements with multiple responses in a pretested questionnaire format to gather and understand the current prescription practices, clinical observation and preferences for managing diabetes with a special reference to the clinical use of sitagliptin in Indian settings. The survey respondents were specialists with expertise in managing diabetes. Results: According to 49% of clinicians, the preferred drug combination for managing diabetes with hemoglobin A1C (HbA1C) levels &gt;9% is dipeptidyl peptidase 4 inhibitors (DPP4i) + metformin + glimepiride. The majority of clinicians (89.92%) recommended sitagliptin as the preferred gliptin for cardiovascular (CV) protection in diabetic patients. Approximately 38% of clinicians considered established cardiovascular outcome trials (CVOT) and CV benefits as decisive factors in prescribing sitagliptin as a first- or second-line therapy for diabetic patients. Around 72% of clinicians preferred sitagliptin + dapagliflozin as an oral antidiabetic (OAD) combination for type 2 diabetes mellitus (T2DM) patients with chronic kidney disease (CKD). Approximately 42% of respondents reported sitagliptin + metformin as the preferred OAD combination, prescribed as a single pill, for uncontrolled T2DM patients with HbA1c levels &gt;8%. Conclusion: The study highlighted the prescription trends favoring sitagliptin-based therapies in the management of diabetes, with potential cardiovascular benefits and as first- or second-line OAD therapy. The respondents also emphasized the significance of personalized approaches, such as the sitagliptin + dapagliflozin combination, for T2DM patients with CKD.

Efficacy of Empagliflozin as Add-on Therapy in Patients with Uncontrolled Type 2 Diabetes Mellitus

Background: Metformin is recommended as first-line pharmacotherapy for patients with type 2 Diabetes Mellitus (T2DM) who fail to achieve glycemic control through lifestyle modification. Metformin initially lowers blood glucose, but as diabetes progresses, it alone frequently fails to maintain glycemic control, and additional therapies are required. Empagliflozin is a potent and selective sodium-glucose co-transporter 2 (SGLT2) inhibitor that is effective in reducing blood sugar levels as monotherapy or add-on to existing therapy with significant improvements in glycemic control and weight.&#x0D; Materials &amp; Methods: This quasi-experimental study was conducted in the Department of Pharmacology and Therapeutics in collaboration with Rajshahi Diabetic Association General Hospital, Rajshahi, for one year from January 2021 to December 2021 on 50 uncontrolled T2DM patients (glycosylated hemoglobin, HbA1c &gt; 7.0 to ≤ 10.5%) for more than 12 weeks. The investigating drug, empagliflozin 10 mg (1 tablet) as a once-daily dose, was added to the ongoing treatment of each patient as 3rd line treatment and was followed up at 6 and 12 weeks.&#x0D; Results: The mean FBS at baseline was 10.8 mmol/L, which declined to 8.5 mmol/L at six weeks and then to 7.2 mmol/L after 12 weeks of intervention with Empagliflozin as add-on therapy in patients with uncontrolled T2DM. The overall reduction of FBS from baseline to 12 weeks of intervention was statistically significant (p &lt; 0.001). Simultaneously the mean HbA1c also reduced from 9.4% to 7.7% after six weeks and to 7.1% after 12 weeks of intervention (p &lt; 0.001). The mean systolic and diastolic blood pressures decreased from 129 mmHg to below 120 mmHg (p &lt; 0.001) and 82.3 mmHg to below 80 mmHg (p = 0.029), respectively, after three months of intervention.&#x0D; Conclusion: Empagliflozin as add-on therapy responded well in patients with uncontrolled T2DM (previously treated with metformin combined with either sulfonylurea or DPP-4 inhibitors and/or supplemented by insulin) in achieving glycemic control. &#x0D; TAJ 2022; 36: No-1: 89-95

Social determinants of health and quality of life among uncontrolled type 2 diabetes mellitus: a review

Diabetes mellitus (DM) is a public health issue; type 2 DM (T2DM) is one of the major causes of increased risks of several diseases and complications. The management and better glycemic control reduce the risk of complications associated with diabetes and improve the quality of life (QOL) of patients. There is a need to consider the external factors indicated as social determinants of diabetes and health to maintain and achieve the goal of sustainable improvement in health outcomes among diabetic patients. This review was aimed at reviewing the social determinants of health (SDOH) and the QOL of uncontrolled T2DM patients. The online databases PubMed, Science Direct, Research Gate, and Google Scholar were used to perform a literature search for publications published between 2010 and 2021, without any date or language restrictions. We used a combination of relevant search terms &amp;quot;DM, T2DM, Uncontrolled T2DM, QOL, health-related quality of life, SDOH&amp;quot;. We independently identified publications and systematically screened titles, abstracts, and full texts of the collected publications. The findings included in our review were original articles, review articles, and systematic reviews written in English and focused on our objective. The obtained articles were reviewed and selected based on the inclusion criteria. The QOL of T2DM patients was found low, especially among patients with uncontrolled diabetes and those with diabetes-associated complications. There was interference observed between SDOH and patients&amp;apos; QOL.

A preliminary study to evaluate the impact of pharmaceutical care services on clinical outcome and medication adherence in type 2 diabetes mellitus patients from Ethiopian perspective.

The role of clinical pharmacist in hospital settings of Ethiopia is still new and infant. To evaluate the impact of pharmaceutical care on clinical outcome and medication adherence in type 2 diabetes mellitus (T2DM) patients. A single cantered, pre-post interventional study design was carried out by enrolling 100 uncontrolled T2DM patients from March 1-August 30, 2020. The intervention package included assessment of pharmacological and non-pharmacological needs, counselling patients in person at the clinic, and providing educational materials. Of the 100 patients initially enrolled, 87(87%) completed the follow-up and included in the final data analysis. The intervention showed a decrease in average FBG, systolic blood pressure (SBP), low density lipoprotein cholesterol (LDL-C) by 47.3 mg/dL, 22.6mmHg and 31.4mg/dL, while high density lipoprotein cholesterol (HDL-C) and estimated glomerular filtration rate (eGFR) exhibited significant increase by 13.4 mg/dL and 11.5 ml/min/1.73m2 respectively (p<0.0001). In addition, diastolic blood pressure, lipid values, kidney function parameters, and liver function parameters showed significant decrease in post intervention compared to pre-intervention (p<0.05). Medication adherence of the patients increased significantly at 6-month follow-up (p<0.001). These results also suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare teams and diabetes management in Ethiopia.

Effects of DPP-4 inhibitors on brain natriuretic peptide, neuropeptide Y, glucagon like peptide-1, substance P levels and global longitudinal strain measurements in type 2 diabetes mellitus patients

Introduction: Previously, a significant relationship between saxagliptin treatment and increased rate of hospitalization for congestive heart failure was reported. We aimed to investigate effects of vildagliptin and saxagliptin on brain natriuretic peptide (BNP), neuropeptide Y (NPY), substance P (SP), glucagon like peptide-1 (GLP-1) levels and left ventricular global longitudinal strain (GLS), assessed by 3-dimensional speckle tracking echocardiography in uncontrolled type 2 Diabetes mellitus (T2DM).&#x0D; Material and method: Thirty seven uncontrolled T2DM (HbA1c&gt;7,5%) patients who were recently prescribed to either vildagliptin 50 mg BID (n=21) or saxagliptin 5 mg QD (n=16) were included in this study. Levels of BNP, NPY, SP, GLP-1 levels were measured at admission, first and third months of treatment. GLS was measured at admission and third month. &#x0D; Results: In whole group, BNP and NPY values increased significantly at third month of treatment (p&lt; 0.001, 0.004; respectively). In the vildagliptin group, BNP and NPY values increased significantly at third month of treatment (p=0.02 and p=0.04, respectively). In the saxagliptin group only BNP levels increased significantly (p=0.015). In both groups; SP, GLP-1 levels and GLS measurements did not change significantly during follow-up period. &#x0D; Conclusion: The current study demonstrated that treatment with saxagliptin and vildagliptin, was associated with increased levels of BNP and NPY levels. No evidence of subclinical myocardial damage or cardiac dysfunction could be detected by GLS measurements. Since our study population had no previous clinical cardiac disorders, increases in BNP and NPY levels with these two DPP4 inhibitors can be considered as a safety signal.

Independent Association of 25[OH]D Level on Reduced Glutathione and TNF-α in Patients ‎with Diabetes and/or Hypertension.

PurposeOxidative and inflammatory pathways play a significant role in the pathophysiology of a wide variety of non-communicable diseases such as type 2 diabetes mellitus (T2DM) and hypertension. However, the effect of serum 25-hydroxyvitamin D ‎‎(25[OH]D) on these pathways is still controversial. To evaluate the association of 25[OH]D on ‎antioxidant and pro-inflammatory biomarkers, reduced glutathione (GSH) and tumor ‎necrosis factor (TNF)-α, in T2DM and hypertensive patients.Patients and MethodsThis is a cross-sectional study of a consecutive sample of patients attending the the Family Medicine clinic at King Abdullah bin Abdulaziz University Hospital (KAAUH). Participants were screened for eligibility according to the following ‎criteria: aged above 18 years and diagnosed with T2DM and/or hypertension for at least one ‎year. Patients receiving any kind of vitamin D or calcium supplements within the last three ‎months were excluded, as were those with a history of ‎renal failure, cancer, liver, thyroid, or any other chronic inflammatory diseases.ResultsIn total 424 T2DM and/or ‎hypertensive patients (mean age 55±12 years) were recruited. In addition to routine ‎physical and laboratory examinations, levels of serum 25[OH]D, GSH and TNF-α were ‎measured. The prevalence of 25[OH]D deficiency (<50 nmol/L) was 35.1%, which was ‎independent from GSH and TNF-α levels. In T2DM, hypertensive and patients having ‎both diseases, GSH levels were 349.3±19, 355.4±19 and 428.8±20 μmol/L, ‎respectively. Uncontrolled T2DM and hypertension patients showed significantly higher ‎GSH compared with the controlled group. ‎Males showed slightly higher level ‎of TNF-α compared with females and uncontrolled hypertensive patients had relatively ‎higher TNF-α level when evaluated against controlled hypertensive patients. ‎Conclusion25[OH]D level is independent of oxidative stress and inflammation, ‎assessed by levels of GSH and TNF-α, respectively, in T2DM and hypertensive Saudi ‎patients. ‎

Serum Activities of Ferritin Among Controlled and Uncontrolled Type 2 Diabetes Mellitus Patients.

BackgroundDiabetes mellitus (DM) is a metabolic disorder characterized by the cells' inefficient utilization of blood glucose. DM occurs in two types: type 1 DM (T1DM) and type 2 DM (T2DM). DM results in increased blood sugar levels attributed to the non-functioning of the insulin-producing islet cells of the pancreas (type 1 DM) and insulin resistance, among other causes. Despite the initiation of treatment, in some people, diabetes remains uncontrolled and, over some time, could cause damage to other organs of the body, including the eyes, heart, and kidneys, among others. Recently, it was observed that iron metabolism and increased activity of serum ferritin (hyperferritinemia) could influence the development of T2DM. This study aims to assess the activities of ferritin among controlled and uncontrolled T2DM patients and compare them with the control group who were non-diabetic.MethodsThe study included 30 controlled and uncontrolled T2DM patients and an equal number of controls. The study was conducted between September and October 2021, and all patients included were those attending the General Medicine outpatient department attached to the RVM Institute of Medical Sciences and Research Centre, Siddipet, Telangana, South India. Blood glucose activities were estimated by the glucose oxidase-peroxidase (GOD-POD) method using the Randox Daytona plus analyzer, and serum ferritin was measured by the chemiluminescence method using the Beckmann Coulter Access 2 instrument.ResultsThe mean age of the cases and the controls was 56.5 years and 46.7 years, respectively. Serum ferritin activities among people with controlled diabetes (73.3±56.6 ng/ml) (p=0.0003) and uncontrolled diabetes (269.8±347.1 ng/ml) (p=0.0006) varied significantly as compared to the controls (40.853±15.55). Glucose activities among controls (82.9±7.4 mg/dl), controlled T2DM patients (120.9±28.6 mg/dl), and uncontrolled T2DM patients (316.06±145.41 mg/dl) also showed significant differences.ConclusionHyperferritinemia is evident among uncontrolled T2DM patients. However, increased serum ferritin activities were also noted among controlled T2DM patients as compared to normal activities observed in the non-diabetic control group.

Distinct pathoclinical clusters among patients with uncontrolled type 2 diabetes: results from a prospective study in rural India

IntroductionInadequate glycemic control among patients with type 2 diabetes mellitus (T2DM) poses an enormous challenge. Whether this uncontrolled T2DM population is a heterogenous mix of disease subtypes remains unknown. Identification...

Serum 25-OH Cholecalciferol (Vitamin D) Levels among Patients with Uncontrolled Type 2 Diabetes Mellitus- A Case-control Study

Introduction: Type 2 Diabetes Mellitus (T2DM), a common metabolic disorder characterised by hyperglycaemia is caused due to an absolute or relative insulin deficiency and/or insulin resistance. Vitamin D, a steroid hormone beyond its primary role on calcium and bone metabolism, also has been shown to have multiple other effects. Vitamin D levels have been studied in relation to glucose metabolism as role in insulin secretion and insulin resistance by many studies in the past. Aim: To estimate the levels of serum 25-OH vitamin D and to correlate with glycaemic status among uncontrolled T2DM patients. Materials and Methods: A case-control study was conducted during August-September 2021 at Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research in Melmaruvthur, Tamil Nadu, India. In this study, 50 cases (uncontrolled T2DM) and 50 controls (healthy individuals), of both sexes aged between 40- 60 years were included. Blood samples were analysed for serum 25-OH cholecalciferol (Vitamin D), fasting and postprandial plasma glucose levels and statistical analysis was done by Independent sample t-test for significance testing, odds ratio for exposureoutcome association by logistic regression and Pearson coefficient for correlation using Statistical Package for the Social Sciences (SPSS) software version 18.0. Results: Serum 25-OH vitamin D levels were significantly {p&lt;0.005 (t=-9.005)} lower in cases {31.02±7.51 ng/mL} when compared to controls {48.30±11.29 ng/mL}. Logistic regression showed none of the predictor variables studied showing significant outcome association (p&lt;0.05) for vitamin D predeficiency while Pearson correlation showed significant negative correlation with fasting (r=-0.463) and postprandial plasma glucose (r=-0.568), respectively at 0.01 level (2-tailed). Conclusion: Serum 25-OH Vitamin D levels were significantly lower and have significant inverse association with fasting plasma glucose levels and postprandial plasma glucose levels in uncontrolled T2DM patients. This substantiates the role of vitamin D in maintaining normal plasma glucose levels in T2DM patients. It is thereby proposed that serum 25-OH vitamin D levels be measured and followed-up for better glycaemic control among T2DM patients.

Assessment of Vitamin A and Vitamin E Levels in Patients with Controlled and Uncontrolled Type 2 Diabetes Mellitus: A Case-control Study

Introduction: The prevalence of diabetes in India according to the International Diabetes Federation (IDF), Diabetes Atlas 2015 is reported to be 8.7%. Diabetes mellitus is a metabolic disorder, which results from body’s insensitivity to insulin and affects humankind at an alarming pose. Glycated Haemoglobin (HbA1c) is an important biomarker in assessing glucose level serologically. If HbA1c level is &lt;7% the diabetes is said to be in controlled conditions. Vitamin A and E plays pivotal role as antioxidants in order to control oxidative stress which is an important contributing factor in diabetes mellitus by neutralising free radicals generated. Aim: To assess the antioxidants vitamin A and vitamin E levels in controlled and uncontrolled Type 2 Diabetes Mellitus (T2DM) patients and also to correlate the vitamin A and E levels with HbA1C in controlled and uncontrolled T2DM patients. Materials and Methods: The present case-control study was conducted for 12 months from January 2019 to December 2019 in the Department of Biochemistry, Jawaharlal Nehru Medical College Belagavi, Karnataka, India. The blood samples were collected from KLE’S Dr. Prabhakar Kore Hospital and Medical Research Center, Belagavi, Karnataka, India. A total of 110 subjects were divided into two group’s controlled Group 1 (55) and uncontrolled Group 2 diabetes (55) on the basis of HbA1c levels. Vitamin A and E levels were assessed by Enzyme Linked Immunosorbent Assay (ELISA) method. HbA1c was estimated by using Bio-Rad D-10 HbA1c program. The data was assessed using Chi-square test, Independent t-test, and Karl-Pearson corelation test. Results: There were a total of 29 males and 26 females in controlled T2DM group and a total of 34 males and 21 females in uncontrolled T2DM group. The mean ages in controlled and uncontrolled T2DM subjects were 57.11±8.82 years and 54.22±7.93 years respectively. The HbA1c (%), vitamin E and vitamin A in controlled T2DM subjects were 6.01±0.56 years, 1.01±0.43 years and 21.66±7.94 years respectively. The HbA1c (%), vitamin E and vitamin A in uncontrolled T2DM subjects were 9.31±0.25 years, 0.58±0.29 years and 14.66±5.36 years respectively. Corelation of vitamin A and E with HbA1c was found to be non significant statistically. Conclusion: Vitamin A and E levels were comparatively higher in controlled diabetes patients in comparison to uncontrolled T2DM patients.

Efficacy and safety of Trikgudas an add-on medicine in uncontrolled type 2 diabetes mellitus (T2DM) patients with metformin monotherapy: A randomized controlled trial

Metformin is quite effective in managing Type 2 diabetes mellitus (T2DM). Studies have reported that the combined use of oral hypoglycemic medicines is prescribed in uncontrolled T2DM metformin monotherapy. So, we aim to evaluate the efficacy and safety of Ayurvedic herbo-mineral formulation (Trikgud) in managing uncontrolled T2DM with metformin monotherapy in Nepalese population. This study was a randomized, double-blind, and controlled trial. A total of 56 participants with the diagnosis of T2DM were randomly assigned to the intervention group (Trikgudmet) or control (Met) group in a ratio of 1:1 for 12weeks. The primary outcome measure was was the difference in the change in glycated haemoglobulin (HbA1C), fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (2-h PPG) between the groups, and secondary outcome measures was the change in body mass index (BMI), waist-hip ratio (WHR), lipid profile, liver function tests and renal function tests between the baseline and at 12weeks after intervention. At week 12, there were significant differences of FPG and 2-h PPG in both Trikgudmet group and Met group when compared with week 0. There was a statistically significant decrease of 8.6% and 10.1% of HbA1C levels in Trikgumet and Met groups, respectively. This study may provide new evidence for use of Trikgudas an add-on therapy for uncontrolled T2DM patients with metformin monotherapy in context of Nepal.

211-OR: Differential Cerebral Blood Flow in Controlled and Uncontrolled Patients with Type 2 Diabetes Mellitus

Introduction: Patients with type 2 diabetes mellitus (T2DM) show variable brain tissue changes and mood and cognitive symptoms, which may result from altered cerebral blood flow (CBF). However, the regional CBF status in controlled and uncontrolled T2DM patients remains unclear, which can be examined with arterial spin labeling (ASL) imaging. Our aim was to examine regional CBF between controlled and uncontrolled T2DM patients using ASL imaging procedures. Methods: We collected hemoglobin A1c (A1C) data and 3D pseudo-continuous ASL data from 32 T2DM patients (16 controlled [A1C &amp;lt; 7%], age, 56.5±6.5 years; BMI, 29.6±6.2 kg/m2; 8 female; 16 uncontrolled [A1C ≥ 7%], age, 57.6±7.5 years; BMI, 30.0±5.1 kg/m2; 11 female) using a 3.0-Tesla MRI. A1C was measured by point-of-care testing. Whole-brain CBF maps were calculated, normalized to a common space, smoothed, and compared between groups (controlled T2DM patients vs. uncontrolled T2DM patients) using analysis of covariance (SPM12; covariates, age and sex; p&amp;lt;0.05). Results: No significant differences in age or sex appeared between groups. Multiple brain areas showed decreased CBF values in the cingulate, caudate, putamen, insula, hippocampus, amygdala, thalamus, hypothalamus, midbrain, cerebellum, prefrontal and frontal, and temporal cortices in uncontrolled T2DM patients over controlled T2DM patients. However, few brain sites in controlled T2DM patients, including the cerebellum, pons, medulla, parahippocampal gyrus, and temporal cortices showed reduced CBF over uncontrolled T2DM patients. Conclusion: Uncontrolled T2DM patients show significant reduction in CBF compared to controlled T2DM in areas that are involved in mood and cognition regulation. The findings suggest that uncontrolled levels may contribute to reduce regional CBF leading to site-specific tissue changes resulting to mood and cognition deficits in the condition. Disclosure S. E. Choi: None. B. Roy: None. M. Freeby: Research Support; Self; Abbott Diabetes, Novo Nordisk Inc. R. Kumar: None. Funding National Institutes of Health (1R01NR017190-03, 3R01NR017190-03S1)

553-P: Brain Microstructural Tissue Changes in Patients with Controlled and Uncontrolled Type 2 Diabetes

Patients with type 2 diabetes mellitus (T2DM) show brain tissue changes in mood and cognitive control sites. However, it is unclear whether brain microstructural tissue changes differ between patients with controlled (hemoglobin A1c [A1C] &amp;lt;7%) and uncontrolled (A1C ≥ 7%) T2DM. Diffusion tensor imaging (DTI) based mean diffusivity (MD) measures water molecular motion within tissue and shows microstructural changes by values reduced in acute and increased in chronic pathological conditions. Methods: We collected DTI and A1C data from 37 T2DM patients (15 controlled; age 56.4±6.8 years, BMI 29.2±6.2 kg/m2, diabetes duration 6.0±4.8 years, A1C 6.2±0.4%, 7 female; 22 uncontrolled; age 57.2±7.4 years, BMI 30.5±5.1 kg/m2, diabetes duration 15.0±9.0 years, A1C 8.2±1.3%, 14 female) and 12 healthy controls (age 54.3±8.2 years, BMI 25.9±4.6 kg/m2, A1C 5.2±0.4%, 5 male) using a 3.0-Tesla magnetic resonance imaging scanner and point-of-care A1C testing. Whole-brain MD maps were calculated, normalized to a common space, smoothed, and compared between groups (controlled T2DM patients vs. healthy controls; uncontrolled T2DM patients vs. healthy controls) using ANCOVA (SPM12; covariates, age and sex; uncorrected threshold, p&amp;lt;0.005). Results: No significant differences appeared between groups in age or sex. Mean duration of diabetes was significantly different between controlled and uncontrolled T2DM patients (p &amp;lt;0.001). Uncontrolled T2DM patients showed increased MD values in multiple brain areas, including the cingulate, insula, para-hippocampal, hippocampus, cerebellum, basal-forebrain, prefrontal, frontal, and temporal cortices over controlled T2DM patients and healthy controls. Conclusion: Uncontrolled T2DM patients show widespread chronic brain microstructural changes in areas that are involved in mood and cognition regulation. The findings support tight glycemic control to prevent further brain tissue damages in patients with T2DM. Disclosure S.E. Choi: None. B. Roy: None. M. Freeby: Research Support; Self; Abbott, Novo Nordisk Inc. M.A. Woo: None. R. Kumar: None. Funding National Institutes of Health (R01NR017190)

Preoperative predictors of early relapse/no-remission of type-2 diabetes after metabolic surgery in Chinese patients.

Remission of type 2 diabetes mellitus (T2DM) after metabolic surgery in some patients is not sustained. There is limited data regarding the preoperative factors predicting early relapse of T2DM in Chinese patients. The objective of this study is to look for preoperative predictors of early T2DM relapse/no remission in patients with obesity and diabetes who underwent Roux-en-Y gastric bypass (RYGB) or loop duodeno-jejunal bypass with sleeve gastrectomy (LDJB-SG). This is a retrospective study of 113 patients who underwent RYGB or LDJB-SG for T2DM. All T2DM patients with BMI 27.5 to 37.5 kg/m2 , having uncontrolled diabetes and T2DM patients with BMI > 37.5 were included in the study. A multivariate analysis with a logistic regression model was used for analysed factors. Nineteen patients (16.8%) had early relapse and 12 (10.6%) did not have remission. Mean age of patients was significantly more who relapsed/no-remission (44.9 vs 40.3 years). On univariate analysis, base line weight (86 vs 96.7 kg) was significantly lower in patients who relapsed/no-remission. Patients with sustained remission had statistically significant low glycosylated haemoglobin (P < .030), plasma glucose (120 minutes) (P < .002) on OGTT, area under curve glucose (P < .011) values and more C-peptide (P < .006) on univariate analysis. Only duration of diabetes (OR 2.78, 95% CI 1.56-4.97, P < .001) was found to be independent preoperative factor associated with early relapse/no-remission. Two years of diabetes duration was the cut-off point to predict relapse/no-remission (sensitivity 78.9, specificity 63.4, receiver operating characteristic curve 0.71). Duration of diabetes is the most probable, independent preoperative predictor of early T2DM relapse/no-remission in patient with obesity and diabetes undergoing metabolic surgery.

Barriers to Effective Diabetes Mellitus Self-Management (DMSM) Practice for Glycemic Uncontrolled Type 2 Diabetes Mellitus (T2DM): A Socio Cultural Context of Indonesian Communities in West Sulawesi.

Diabetes mellitus self-management (DMSM) is an essential strategy used to maintain blood glucose levels and to prevent severe complications. Several barriers have been documented while implementing DMSM practices. A qualitative study aimed to explore barriers to effective DMSM practice among uncontrolled glycemic type 2 diabetes mellitus (T2DM) patients in Indonesia. We conducted in-depth interviews and focus group discussions (FGDs) among 28 key informants, including patients, family members, healthcare providers (HCPs), and village health volunteers (VHVs). The interviews and FGDs were audiotaped and transcribed verbatim. The results revealed six core themes with sub-categories of themes used by all participants to describe the barriers to effective DMSM practice among uncontrolled T2DM patients. The critical barriers of DMSM practice included low perception of susceptibility to and severity of the illness; inadequate knowledge and skill of diabetes mellitus self-management; lack of motivation to perform diabetes mellitus self-management; insufficient human resources; lack of social engagement; and social exclusion and feelings of embarrassment. Our findings provide valuable information regarding the barriers while implementing the DMSM practice. Healthcare providers should negotiate with both T2DM patients and caretakers to participate in a DMSM program at a community health care level.

Advanced glycation end products (AGEs) and their soluble receptors (sRAGE) as early predictors of reno-vascular complications in patients with uncontrolled type 2 diabetes mellitus

AimTo evaluate the role of advanced glycation end-products (AGEs) and their soluble receptors (sRAGE) expression levels as predictors of vascular complications in uncontrolled type 2 diabetes mellitus (T2DM). MethodsCross-sectional study was conducted on T2DM adults of both sexes who attended the outpatient service of Al-Karak Teaching Hospital, Jordan during the period from June 2017 to August 2018. Participants were categorized in two groups according to their glycemic control and the presence of reno-vascular complications. Twenty healthy subjects were recruited as control group. Blood sample was obtained from all participants and used for the assessment of FBG, HbA1c, serum AGEs and sRAGE, serum urea and creatinine; 24 h urine was also collected for the determination of urinary albumin. ResultsDiabetic subjects with vascular complication had a significantly higher serum AGEs 50.3 ± 13 vs. 28.9 ± 8 pg/ml) and AGEs/sRAGE ratio (0.058 ± 0.02 vs. 0.037 ± 0.02) associated with significantly lower serum sRAGE (868.7 ± 50.8 vs. 912.8 ± 294.3) compared to those with no complications. Serum AGEs and sRAGE showed weak negative and non-significant association in both groups of patients. However, the AGEs/sRAGE ration was inversely and significantly associated with the urinary albumin/creatinine ratio (r = − 0.51, P = 0.009) only in DM patients with reno-vascular complications. ConclusionWe found an association between AGEs/sRAGE ratio and urinary albumin/serum creatinine ratio in T2DM patients with reno-vascular complications; providing evidence that serum AGEs and sRAGE can be considered as predictors of vascular complications in uncontrolled T2DM patients.

A study to assess clinical profile of Indian type 2 diabetes mellitus patients treated with Teneligliptin-ASPIRE study

Background: Teneligliptin is a DPP-4 inhibitor with unique chemical structure. Efficacy and safety of Teneligliptin is well established in the patients with type 2 diabetes mellitus (T2DM) in different randomized controlled trials. However, limited real-world data is available for Teneligliptin pertaining to Indian T2DM patient profile such as demographics, duration of disease, currently prescribed anti-hyperglycemic drugs, initiation of Teneligliptin as monotherapy or as an add on therapy.Methods: A cross-sectional, multicenter, non-interventional study was conducted to understand the demographics and clinical profile of Indian T2DM patients (n=5091) who were prescribed Teneligliptin.Results: Majority of patients were male (65.2%) with family history of T2DM present in 43.45% of cases. Age at onset of T2DM was 51.1±11.6 years. Among the T2DM patients, 36.2% of patients were newly diagnosed and more than half of them (54.7%) were uncontrolled with current anti-hyperglycemic drugs. Mean HbA1c level among these patients was 8.09±1.3%. Mean fasting and postprandial blood glucose levels were 170.2±46.9 mg/dl and 255.3±69.3 mg/dl respectively. Teneligliptin was prescribed as monotherapy in 2165 (41.66 %) of patients while as dual, triple and quadruple therapy in 2346 (46.08%) and 551 (10.82%) and 29 (0.56%) respectively. Among the patients on current anti-hyperglycemic treatment, most commonly prescribed drugs along with Teneligliptin were metformin (43.39%) followed by glimepiride (11%) and voglibose (3.42%).Conclusions: Teneligliptin is preferred as monotherapy and combination with metformin and sulfonylureas (mostly glimepiride) in newly diagnosed and uncontrolled T2DM patients in Indian scenario.