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[Baseline characteristics and quality of life in patients with Diabetes Mellitus included in the EIRA randomized clinical trial.].
Represas-Carrera, FJ, Méndez-López, F, Couso-Viana, S, Masluk, B, Magallón-Botaya, R, Clavería, A
Revista espanola de salud publica. 2021
Abstract
OBJECTIVE The EIRA study is a randomized clinical multicenter trial that aims to evaluate the effectiveness of a complex multi-risk intervention aimed at people aged 45-75 in Primary Care. The objectives of this work were to describe the baseline characteristics of patients with Diabetes Mellitus included in phase III of the EIRA study and analyze the relationship that different independent variables may have with the quality of life. METHODS The data of all patients with Diabetes Mellitus that were included in phase III of EIRA study collected at baseline were analyzed. Patients with at least two or more of unhealthy lifestyles were selected: smoking, low adherence to the Mediterranean diet and/or low level of physical activity. The quality of life was measured with the EQ-5D-5L questionnaire. A descriptive and bivariate study was performed. The variables did not follow a normal distribution. Non-parametric statistical tests were used. For the multivariate analysis of the quality of life, automated linear regression was used with SPSS v19. RESULTS 694 were patients included with Diabetes Mellitus (356 controls, 338 in intervention, without significant differences between both groups). Control: 37.64% women, age (median) 60 years. Intervention: 37.87% women, age (median) 60 years. Most prevalent risk behaviors in descending order: low adherence to the Mediterranean diet, low level of physical activity and smoking. The variables that significantly influenced quality of life were: GAD-7, work activity, HbA1c and CIDI. CONCLUSIONS There are no significant differences motivated by the study design. The influence of mental health on the EQ-5D-5L is remarkable.
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Considering serum alanine aminotransferase and gamma-glutamyltransferase levels together strengthen the prediction of impaired fasting glucose risk: a cross-sectional and longitudinal study.
Jeong, JH, Jung, S, Kim, KN
Scientific reports. 2021;(1):3333
Abstract
Emerging data suggest that an increase in serum alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) as biomarkers of oxidative stress are associated with increased risk of impaired fasting glucose (IFG). The present study was an investigation of whether an increase in serum ALT and GGT had a combined effect on increasing IFG risk through cross-sectional and longitudinal studies. In the cross-sectional study, data were analyzed from 9937 subjects without diabetes who underwent health check-ups between 1999 and 2001 (baseline data). In the longitudinal study, 6390 subjects were analyzed who had been rechecked between 2009 and 2014, excluding IFG patients from baseline data. In cross-sectional analysis, adjusted odds ratio (OR) of IFG in the fourth quartile of both ALT and GGT was 1.829 (95% confidence interval [CI] 1.545-2.164) compared with the reference group (1st and 2nd quartiles of ALT and GGT). In longitudinal analysis, IFG probability increased gradually with an increase in the circulating levels of ALT and GGT. Adjusted hazard ratios for developing IFG in the fourth quartile of both ALT and GGT was 1.625 (95% CI 1.263-2.091) compared with the reference group (1st and 2nd quartiles). Increased serum ALT and GGT levels are well associated with IFG after potential confounders are adjusted for, and elevated ALT and GGT at the same time can have a combined effect in predicting the development of IFG.
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A randomized control trial of duloxetine and gabapentin in painful diabetic neuropathy.
Khasbage, S, Shukla, R, Sharma, P, Singh, S
Journal of diabetes. 2021;(7):532-541
Abstract
BACKGROUND To analyze the efficacy and safety of duloxetine and gabapentin in painful diabetic neuropathy (PDN). METHODS A randomized, open-label, active control, 12-week trial was conducted. A total of 86 participants were randomized in 1:1 ratio into gabapentin 300 mg and duloxetine 60 mg groups. The primary efficacy objective was comparison of mean change in Visual Analogue Scale (VAS) (0-100 points) scores between duloxetine and gabapentin. The symptom scores and adverse events were assessed as secondary outcomes. RESULTS Statistically significant (P value<.001) improvement was observed in VAS scores in both duloxetine group and gabapentin group at 12 weeks as compared to baseline. However, no significant difference in VAS scores between duloxetine and gabapentin. Similar improvement in diabetic neuropathy symptoms (DNS), diabetic neuropathy examination (DNE), and neuropathic disability score (NDS) was observed in either group over 12 weeks. There were no significant differences in DNS (P = 0.578), DNE (P = 0.410), and NDS (P = 0.071) scores between the two treatment groups. The overall safety evaluation of both duloxetine and gabapentin were similar. The most common adverse events reported were gastrointestinal. CONCLUSION The results indicated that both drugs were effective for the symptomatic relief from PDN and had similar efficacy. Follow-up of patients was only for 12 weeks and therefore the long-term efficacy and safety of the study drugs could not be assessed.
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Prediction of Hypoglycemia During Admission of Non-Critically Ill Patients: Results from the MENU Study.
Khanimov, I, Ditch, M, Adler, H, Giryes, S, Felner Burg, N, Boaz, M, Leibovitz, E
Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme. 2020;(9):660-668
Abstract
The objective of the work was to study admission parameters associated with an increased incidence of hypoglycemia during hospitalization of non-critically ill patients. Included in this cross-sectional study were patients admitted to internal medicine units. The Nutritional Risk Screening 2002 (NRS2002) was used for nutritional screening. Data recorded included admission serum albumin (ASA) and all glucose measurements obtained by the institutional blood glucose monitoring system. Neither of these are included in the NRS2002 metrics. Hypoalbuminemia was defined as ASA<3.5 g/dl. Patients were categorized as hypoglycemic if they had at least one documented glucose≤70 mg/dl during the hospitalization period. Included were 1342 patients [median age 75 years (IQR 61-84), 51.3% male, 52.5% with diabetes mellitus, (DM)], who were screened during three distinct periods of time from 2011-2018. The incidence of hypoglycemia was 10.8% with higher rates among DM patients (14.6 vs. 6.6%, p<0.001). Hypoglycemia incidence was negatively associated with ASA regardless of DM status. Multivariable regression showed that ASA (OR 0.550 per g/dl, 95% CI 0.387-0.781, p=0.001) and positive NRS2002 (OR 1.625, 95% CI 1.072-2.465, p=0.022) were significantly associated with hypoglycemia. The addition of hypoalbuminemia status to the NRS2002 tool improved the overall sensitivity from 0.55 to 0.71, but reduced specificity from 0.63 to 0.46. The negative predictive value was 0.93. Our data suggest that the combination of positive malnutrition screen and hypoalbuminemia upon admission are independently associated with the incidence of hypoglycemia among non-critically ill patients, regardless of diabetes mellitus status.
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Screening coronary angiography in patients with long-standing diabetes mellitus undergoing kidney transplant evaluation.
Puttarajappa, CM, Tevar, AD, Hariharan, S, Silver, SJ, Soman, P, Hendrick, S, Mour, G, Wu, CM
Clinical transplantation. 2019;(4):e13501
Abstract
BACKGROUND The utility of coronary angiography in patients with diabetes mellitus undergoing kidney transplant evaluation is unclear. Predictors of critical angiography lesions in these patients will aid in appropriate use of angiography. METHODS Single-center study of 80 patients with ≥15 years of diabetes mellitus who underwent a screening coronary angiography despite a negative cardiac stress test. Risk factors for needing coronary intervention (CI) (percutaneous or bypass grafting) were analyzed. RESULTS Eighteen patients (23%) had a ≥70% occlusion in one or more major coronary vessel(s), with right coronary artery being the most commonly involved (71%). Fifteen patients (19%) underwent coronary intervention: ten percutaneously and five with bypass surgery. Risk factors for needing CI were not being on statin (OR 3.54, P = 0.047) and history of stroke or peripheral vascular disease (PVD; OR 3.5, P = 0.034). A model that included statin use, stroke/PVD history, and glycosylated hemoglobin had a receiver operating characteristic curve area under the curve of 0.8 to predict CI. CONCLUSION Despite a negative stress test, the prevalence of critical coronary lesions was high among kidney transplant candidates with long-standing diabetes. Risk factors for needing coronary intervention were absence of statin use and a history of stroke or peripheral vascular disease.
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Serum Carotenoids and Risks of Diabetes and Diabetic Retinopathy in a Chinese Population Sample.
She, C, Shang, F, Zhou, K, Liu, N
Current molecular medicine. 2017;(4):287-297
Abstract
OBJECTIVE Diabetes mellitus (DM) and diabetic retinopathy (DR) are associated with oxidative stress and carotenoids have antioxidant properties. This study aimed to test the relationship between serum carotenoid concentrations and the risk for DM and DR. METHODS This is a cross-sectional study of the Chinese urban population. A total of 747 subjects, consisting of 272 DR patients, 190 diabetic patients without retinopathy, and 285 non-diabetes mellitus healthy controls, were recruited to this study. Demographic and lifestyle characteristics were ascertained by questionnaire. General physical and ophthalmic examinations were completed for all participants. Serum carotenoids were measured by high-performance liquid chromatography (HPLC). The associations of serum carotenoids with DM and DR were assessed by logistic regression with adjustment of known risk factors. The correlation analyses of serum carotenoids with the candidate influence factors were assessed using the single variable linear regression. RESULTS Both pro-vitamin A (PVA) carotenoids and non-PVA carotenoids in the serum were measured and compared between different groups. Levels of α-carotene were significantly lower in DR patients and β-carotene were significantly lower in DM patients as compared to non DM healthy control group. In contrast, levels of β-cryptoxanthin, lycopene, lutein and zeaxanthin were comparable among different groups. After adjusting for confounding factors, β-carotene concentration was associated with reduced risk for DM (OR (95%CI): 0.56 (0.34, 0.91), P=0.02) and α-carotene was associated with reduced risk for DR in non-smokers (OR (95%CI): 0.41 (0.17, 0.99), P=0.048). No significant association was found between hemoglobin A1c and any carotenoids (P>0.05). Significantly associations with serum carotenoids were found in age, sex, BMI, smoking, and exercise (P<0.05). CONCLUSION Serum β-carotene may have a protective effect on DM and α-carotene may be a protective factor for DR in non-smokers.
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Impaired Oxidative Status Is Strongly Associated with Cardiovascular Risk Factors.
Brunelli, E, La Russa, D, Pellegrino, D
Oxidative medicine and cellular longevity. 2017;:6480145
Abstract
The main target of primary prevention is the identification of cardiovascular risk factors aimed at reducing of the adverse impact of modifiable factors, such as lifestyle and pharmacological treatments. In humans, an alteration of the oxidative status has been associated with several pathologies, including diabetes and cardiovascular diseases. However, the prognostic relevance of circulating oxidative stress biomarkers remains poorly understood. Our study explored, in a healthy population (n = 322), the relationship between oxidative status and cardiovascular risk factors. Here, we were successful in demonstrating that plasmatic oxidative status is significantly associated with traditional cardiovascular risk factors. We revealed a significant depletion in the efficacy of total plasma antioxidant barrier in high cardiovascular risk categories, and we confirmed an age-related alteration of oxidative status. The efficacy of total plasma antioxidant barrier is significantly depleted in relation to metabolic disorders. Interestingly, the cholesterol imbalance is the main factor in depleting the efficacy of total plasma antioxidant barrier. The oxidative status is also influenced by hypertension, and a slight increase in systolic blood pressure determines a highly significant effect. We showed that the first detectable event of a redox disturbance is the repairing intervention of the antioxidant barrier that is thus decreased as overutilized.
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Research into the effect Of SGLT2 inhibition on left ventricular remodelling in patients with heart failure and diabetes mellitus (REFORM) trial rationale and design.
Singh, JS, Fathi, A, Vickneson, K, Mordi, I, Mohan, M, Houston, JG, Pearson, ER, Struthers, AD, Lang, CC
Cardiovascular diabetology. 2016;:97
Abstract
BACKGROUND Heart failure (HF) and diabetes (DM) are a lethal combination. The current armamentarium of anti-diabetic agents has been shown to be less efficacious and sometimes even harmful in diabetic patients with concomitant cardiovascular disease, especially HF. Sodium glucose linked co-transporter type 2 (SGLT2) inhibitors are a new class of anti-diabetic agent that has shown potentially beneficial cardiovascular effects such as pre-load and after load reduction through osmotic diuresis, blood pressure reduction, reduced arterial stiffness and weight loss. This has been supported by the recently published EMPA-REG trial which showed a striking 38 and 35 % reduction in cardiovascular death and HF hospitalisation respectively. METHODS The REFORM trial is a novel, phase IV randomised, double blind, placebo controlled clinical trial that has been ongoing since March 2015. It is designed specifically to test the safety and efficacy of the SLGT2 inhibitor, dapagliflozin, on diabetic patients with known HF. We utilise cardiac-MRI, cardio-pulmonary exercise testing, body composition analysis and other tests to quantify the cardiovascular and systemic effects of dapagliflozin 10 mg once daily against standard of care over a 1 year observation period. The primary outcome is to detect the change in left ventricular (LV) end systolic and LV end diastolic volumes. The secondary outcome measures include LV ejection fraction, LV mass index, exercise tolerance, fluid status, quality of life measures and others. CONCLUSIONS This trial will be able to determine if SGLT2 inhibitor therapy produces potentially beneficial effects in patients with DM and HF, thereby replacing current medications as the drug of choice when treating patients with both DM and HF. Trial registration Clinical Trials.gov: NCT02397421. Registered 12th March 2015.
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Pilot study using mobile health to coordinate the diabetic patient, diabetologist, and ophthalmologist.
Tsui, I, Drexler, A, Stanton, AL, Kageyama, J, Ngo, E, Straatsma, BR
Journal of diabetes science and technology. 2014;(4):845-9
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Abstract
In the United States, more than 25 million adults have diabetes, 40% of diabetics have diabetic retinopathy, and diabetes is the leading cause of blindness in people 20 to 74 years of age. Clinical trials have shown that strict control of blood glucose level and other risk factors delays diabetic retinopathy onset, progression, and vision loss. Patients with Type 1 or Type 2 diabetes mellitus, access to an Apple iPhone or iPad, and no psychological or medical condition that would interfere with the study participated in a nonrandomized clinical trial using SightBook™, a free mobile app that enables self-measurement of visual function and creates a password-protected web account for each patient. Sixty patients enrolled in the clinical trial over a 6 month period. Twenty-six participants were men and 34 were women, with ages from 23 to 72 years (mean 45 ± 15) and diabetes duration of 1.5 to 50 years (mean 15.5 ± 11.5). Thirty-nine (65%) patients reported Type 1 diabetes and 21 (35%) patients reported Type 2 diabetes. Every patient established a personal web account on SightBook and invited participation of treating physicians; 51 (85%) patients completed the validated self-reported outcome assessments. Diabetologist examinations of 49 (82%) patients demonstrated systolic hypertension (≥140 mgHg) in 20% and hemoglobin A1c ≥ 7.0% in 56%. Ophthalmology examinations of 45 patients showed visual acuity in the worse-seeing eye of < 20/40 in 18% and diabetic retinopathy in 42% of patients. This clinical trial used a mobile health app to incorporate diabetic patient self-measurement of vision and coordinate the diabetic patient, diabetologist, and ophthalmologist for control of diabetes and diabetic retinopathy risk factors.
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Non-emphysematous chronic obstructive pulmonary disease is associated with diabetes mellitus.
Hersh, CP, Make, BJ, Lynch, DA, Barr, RG, Bowler, RP, Calverley, PM, Castaldi, PJ, Cho, MH, Coxson, HO, DeMeo, DL, et al
BMC pulmonary medicine. 2014;:164
Abstract
BACKGROUND Chronic obstructive pulmonary disease (COPD) has been classically divided into blue bloaters and pink puffers. The utility of these clinical subtypes is unclear. However, the broader distinction between airway-predominant and emphysema-predominant COPD may be clinically relevant. The objective was to define clinical features of emphysema-predominant and non-emphysematous COPD patients. METHODS Current and former smokers from the Genetic Epidemiology of COPD Study (COPDGene) had chest computed tomography (CT) scans with quantitative image analysis. Emphysema-predominant COPD was defined by low attenuation area at -950 Hounsfield Units (LAA-950) ≥10%. Non-emphysematous COPD was defined by airflow obstruction with minimal to no emphysema (LAA-950 < 5%). RESULTS Out of 4197 COPD subjects, 1687 were classified as emphysema-predominant and 1817 as non-emphysematous; 693 had LAA-950 between 5-10% and were not categorized. Subjects with emphysema-predominant COPD were older (65.6 vs 60.6 years, p < 0.0001) with more severe COPD based on airflow obstruction (FEV1 44.5 vs 68.4%, p < 0.0001), greater exercise limitation (6-minute walk distance 1138 vs 1331 ft, p < 0.0001) and reduced quality of life (St. George's Respiratory Questionnaire score 43 vs 31, p < 0.0001). Self-reported diabetes was more frequent in non-emphysematous COPD (OR 2.13, p < 0.001), which was also confirmed using a strict definition of diabetes based on medication use. The association between diabetes and non-emphysematous COPD was replicated in the ECLIPSE study. CONCLUSIONS Non-emphysematous COPD, defined by airflow obstruction with a paucity of emphysema on chest CT scan, is associated with an increased risk of diabetes. COPD patients without emphysema may warrant closer monitoring for diabetes, hypertension, and hyperlipidemia and vice versa. TRIAL REGISTRATION Clinicaltrials.gov identifiers: COPDGene NCT00608764, ECLIPSE NCT00292552.