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Improvement of Glycemic Control in Insulin-Dependent Diabetics with Depression by Concomitant Treatment with Antidepressants.
Radojkovic, J, Sikanic, N, Bukumiric, Z, Tadic, M, Kostic, N, Babic, R
Medical science monitor : international medical journal of experimental and clinical research. 2016;:2133-43
Abstract
BACKGROUND It is still disputable whether negative effects of comorbid depression in diabetics can be diminished by successful treatment of depression. The primary aim of this study was to assess whether addition of antidepressants to existing insulin treatment would further improve glycemic control in these patients. A secondary objective was to assess whether such treatment impairs their lipid and inflammatory status. MATERIAL AND METHODS Total of 192 patients with poorly controlled diabetes (defined as HbA1c ≥8%) in the absence of any uncontrolled medical condition entered the 6-month run-in phase with optimization of diabetic therapy. Depression status was screened at the end of this phase by BDI-II depression testing. Patients with BDI-II ≥14 and psychiatric confirmation of depression (58 patients) entered the 6-month interventional phase with SSRI class antidepressants. RESULTS Fifty patients completed the study. During the run-in phase, HbA1c dropped from 10.0±1.8% to 8.5±1.2% (p<0.001), and during the interventional phase it dropped from 8.5±1.2% to 7.7±0.7% (p<0.001). BDI-II scores improved significantly from 30.4±13.2 to 23.5±11.0 (p=0.02) during the interventional phase. A positive linear correlation between improvement in depression scale and improvement in glycemic control was observed (R²=0.139, p=0.008). Lipid profile and inflammatory status did not change significantly during the interventional phase. CONCLUSIONS Patients with poorly controlled diabetes and comorbid depression might benefit from screening and treatment of depression with SSRI antidepressants by achieving an incremental effect on glycoregulation. This therapy did not have any adverse effects on lipid profile or inflammatory status.
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Impact of intensive glycemic control on the incidence of atrial fibrillation and associated cardiovascular outcomes in patients with type 2 diabetes mellitus (from the Action to Control Cardiovascular Risk in Diabetes Study).
Fatemi, O, Yuriditsky, E, Tsioufis, C, Tsachris, D, Morgan, T, Basile, J, Bigger, T, Cushman, W, Goff, D, Soliman, EZ, et al
The American journal of cardiology. 2014;(8):1217-22
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Atrial fibrillation (AF) is prevalent in patients with type 2 diabetes mellitus (DM) and is associated with markers of poor glycemic control; however, the impact of glycemic control on incident AF and outcomes is unknown. The aims of this study were to prospectively evaluate if intensive glycemic control in patients with DM affects incident AF and to evaluate morbidity and mortality in patients with DM and incident AF. A total of 10,082 patients with DM from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) cohort were studied in a randomized, double-blind fashion. Participants were randomized to an intensive therapeutic strategy targeting a glycated hemoglobin level of <6.0% or a standard strategy targeting a glycated hemoglobin level of 7.0% to 7.9%. Incident AF occurred in 159 patients (1.58%) over the follow-up period, at a rate of 5.9 per 1,000 patient-years in the intensive-therapy group and a rate of 6.37 per 1,000 patient-years in the standard-therapy group (p = 0.52). In a multivariate model, predictors of incident AF were age, weight, diastolic blood pressure, heart rate, and heart failure history. Patients with DM and new-onset AF had a hazard ratio of 2.65 for all-cause mortality (95% confidence interval 1.8 to 3.86, p <0.0001), a hazard ratio of 2.1 for myocardial infarction (95% confidence interval 1.33 to 3.31, p = 0.0015), and a hazard ratio of 3.80 for the development of heart failure (95% confidence interval 2.48 to 5.84, p <0.0001). In conclusion, intensive glycemic control did not affect the rate of new-onset AF. Patients with DM and incident AF had an increased risk for morbidity and mortality compared with those without AF.
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Glycemic control and the first use of oral antidiabetic agents among patients with type 2 diabetes mellitus.
Mitchell, BD, Eby, EL, Lage, MJ
Current medical research and opinion. 2013;(12):1587-97
Abstract
OBJECTIVE Examine how patients diagnosed with type 2 diabetes mellitus (T2DM) are treated with oral antidiabetic (OAD) agents and the relationship between treatment patterns and glycemic control. RESEARCH DESIGN AND METHODS Data were obtained from the i3 Invision Data Mart database (OptumInsight, Eden Prairie, MN, USA). The analyses examined 4627 individuals who received a first prescription for an OAD (with first date identified as index date) and received at least one HbA1c test in both the 1 year prior and 2 years post index date. Patients were categorized based upon their level of glycemic control pre index date and logistic multivariate analyses were used to examine the probability of a patient's first treatment pattern change being a switch, augmentation, or discontinuation compared to continuation on the intent-to-treat (ITT) OAD. RESULTS Men tended to have worse glycemic control at OAD initiation. During the post-period, younger patients were more likely to switch, augment or discontinue therapy, while patients initially treated with metformin were more likely to switch or augment therapy. Results indicated that patients with moderate or poor glycemic control, compared to those with good glycemic control, were significantly more likely to switch or augment therapy. Practice patterns revealed minimal use of insulin although, on average, many patients were above target HbA1c levels at initiation. Interpretation of results are limited by the fact that only a small subset of patients had valid HbA1c data and that the analyses was not able to account for other factors, such as race and weight, that may also impact the analyses. CONCLUSIONS Patient initial level of glycemic control was associated with changes in treatment patterns in the 2 years post initiation on an OAD, with patients with moderate or poor control more likely to switch or augment their ITT therapy, compared to individuals with good control.
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Effects of voglibose and nateglinide on glycemic status and coronary atherosclerosis in early-stage diabetic patients.
Kataoka, Y, Yasuda, S, Miyamoto, Y, Sase, K, Kosuge, M, Kimura, K, Yoshimasa, Y, Miyazaki, S, ,
Circulation journal : official journal of the Japanese Circulation Society. 2012;(3):712-20
Abstract
BACKGROUND Postprandial hyperglycemia and hyperinsulinemia have been considered as important determinants for the development of atherosclerosis. However, it remains to be elucidated whether correction of the postprandial glycemic status prevents atherosclerotic changes. METHODS AND RESULTS The DIANA (DIAbetes and diffuse coronary NArrowing) study is a prospective randomized open-label multicenter trial. The 302 patients with coronary artery disease (CAD), impaired glucose tolerance/diabetes mellitus (DM) pattern according to 75-g oral glucose tolerance test and HbA(1c) <6.9% were randomly assigned to life-style intervention (n=101), voglibose (0.9 mg/day, n=100) or nateglinide treatment (180 mg/day, n=101). We compared 1-year coronary atherosclerotic changes evaluated by quantitative coronary arteriography. Although voglibose significantly increased the number of patients with normal glucose tolerance at 1 year, there were no significant differences in coronary atherosclerotic changes at 1 year. However, overall, less atheroma progression was observed in patients in whom glycemic status was improved at 1 year (%change in total lesion length: 3.5% vs. 26.2%, P<0.01, %change in averaged lesion length: 0.7% vs. 18.6%, P=0.02). CONCLUSIONS Although coronary atherosclerotic changes were similar for voglibose and nateglinide, an improvement in glycemic status at 1 year was associated with less atheroma progression regardless of the treatment. Our findings underscore the management of glycemic abnormality to prevent coronary atherosclerotic changes in Japanese early-stage DM patients with CAD.
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The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine.
Buse, JB, Wolffenbuttel, BH, Herman, WH, Hippler, S, Martin, SA, Jiang, HH, Shenouda, SK, Fahrbach, JL
Diabetes care. 2011;(2):249-55
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OBJECTIVE This study compared the durability of glycemic control of twice-daily insulin lispro mix 75/25 (LM75/25: 75% insulin lispro protamine suspension/25% lispro) and once-daily insulin glargine, added to oral antihyperglycemic drugs in type 2 diabetes patients. RESEARCH DESIGN AND METHODS During the initiation phase, patients were randomized to LM75/25 or glargine. After 6 months, patients with A1C ≤ 7.0% advanced to the maintenance phase for ≤ 24 months. The primary objective was the between-group comparison of duration of maintaining the A1C goal. RESULTS Of 900 patients receiving LM75/25 and 918 patients receiving glargine who completed initiation, 473 and 419, respectively, had A1C ≤ 7.0% and continued into maintenance. Baseline characteristics except age were similar in this group. Median time of maintaining the A1C goal was 16.8 months for LM75/25 (95% CI 14.0-19.7) and 14.4 months for glargine (95% CI 13.4-16.8; P = 0.040). A1C goal was maintained in 202 LM75/25-treated patients (43%) and in 147 glargine-treated patients (35%; P = 0.006). No differences were observed in overall, nocturnal, or severe hypoglycemia. LM75/25 patients had higher total daily insulin dose (0.45 ± 0.21 vs. 0.37 ± 0.21 units/kg/day) and more weight gain (5.4 ± 5.8 vs. 3.7 ± 5.6 kg) from baseline. Patients taking LM75/25 and glargine with lower baseline A1C levels were more likely to maintain the A1C goal (P = 0.043 and P < 0.001, respectively). CONCLUSIONS A modestly longer durability of glycemic control was achieved with LM75/25 compared with glargine. Patients with lower baseline A1C levels were more likely to maintain the goal, supporting the concept of earlier insulin initiation.
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Blood profile of proteins and steroid hormones predicts weight change after weight loss with interactions of dietary protein level and glycemic index.
Wang, P, Holst, C, Andersen, MR, Astrup, A, Bouwman, FG, van Otterdijk, S, Wodzig, WK, van Baak, MA, Larsen, TM, Jebb, SA, et al
PloS one. 2011;(2):e16773
Abstract
BACKGROUND Weight regain after weight loss is common. In the Diogenes dietary intervention study, high protein and low glycemic index (GI) diet improved weight maintenance. OBJECTIVE To identify blood predictors for weight change after weight loss following the dietary intervention within the Diogenes study. DESIGN Blood samples were collected at baseline and after 8-week low caloric diet-induced weight loss from 48 women who continued to lose weight and 48 women who regained weight during subsequent 6-month dietary intervention period with 4 diets varying in protein and GI levels. Thirty-one proteins and 3 steroid hormones were measured. RESULTS Angiotensin I converting enzyme (ACE) was the most important predictor. Its greater reduction during the 8-week weight loss was related to continued weight loss during the subsequent 6 months, identified by both Logistic Regression and Random Forests analyses. The prediction power of ACE was influenced by immunoproteins, particularly fibrinogen. Leptin, luteinizing hormone and some immunoproteins showed interactions with dietary protein level, while interleukin 8 showed interaction with GI level on the prediction of weight maintenance. A predictor panel of 15 variables enabled an optimal classification by Random Forests with an error rate of 24±1%. A logistic regression model with independent variables from 9 blood analytes had a prediction accuracy of 92%. CONCLUSIONS A selected panel of blood proteins/steroids can predict the weight change after weight loss. ACE may play an important role in weight maintenance. The interactions of blood factors with dietary components are important for personalized dietary advice after weight loss. REGISTRATION ClinicalTrials.gov NCT00390637.
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Dietary carbohydrate, glycemic index, glycemic load, and risk of prostate cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) cohort.
Shikany, JM, Flood, AP, Kitahara, CM, Hsing, AW, Meyer, TE, Willcox, BJ, Redden, DT, Ziegler, RG
Cancer causes & control : CCC. 2011;(7):995-1002
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OBJECTIVE To evaluate the associations between dietary carbohydrate, glycemic index (GI), glycemic load (GL), and incident prostate cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) cohort. METHODS Between September 1993 and September 2000, 38,343 men were randomized to the screening arm of the trial at one of 10 PLCO centers. A food frequency questionnaire administered at baseline assessed usual dietary intake over the preceding 12 months. Prostate cancer was ascertained by medical follow-up of suspicious screening results and annual mailed questionnaires and confirmed with medical records. Cox proportional hazards regression was used to model the associations of carbohydrate, GI, and GL with prostate cancer risk. RESULTS During follow-up (median = 9.2 years), 2,436 incident prostate cancers were identified among 30,482 eligible participants. Overall, there were no associations of baseline carbohydrate, GI, or GL with incident prostate cancer in minimally or fully adjusted models. There were no associations when the 228 advanced and 2,208 non-advanced cancers were analyzed separately. CONCLUSIONS Dietary carbohydrate, GI, and GL were not associated with incident prostate cancer in PLCO. The narrow range of GI in this cohort may have limited our ability to detect associations, an issue that future studies should address.
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The effect of protein and glycemic index on children's body composition: the DiOGenes randomized study.
Papadaki, A, Linardakis, M, Larsen, TM, van Baak, MA, Lindroos, AK, Pfeiffer, AF, Martinez, JA, Handjieva-Darlenska, T, Kunesová, M, Holst, C, et al
Pediatrics. 2010;(5):e1143-52
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OBJECTIVE To investigate the effect of protein and glycemic index (GI) on body composition among European children in the randomized, 6-month dietary intervention DiOGenes (diet, obesity, and genes) family-based study. PATIENTS AND METHODS In the study, 827 children (381 boys and 446 girls), aged 5 to 18 years, completed baseline examinations. Families with parents who lost ≥ 8% of their weight during an 8-week run-in low-calorie diet period were randomly assigned to 1 of 5 ad libitum diets: low protein (LP)/low glycemic index (LGI); LP/high GI (HGI); high protein (HP)/LGI; HP/HGI; and control diet. The target difference was 15 GI U between the LGI/HGI groups and 13 protein percentage points between the LP/HP groups. There were 658 children examined after 4 weeks. Advice on food-choice modification was provided at 6 visits during this period. No advice on weight loss was provided because the focus of the study was the ability of the diets to affect outcomes through appetite regulation. Anthropometric measurements and body composition were assessed at baseline, week 4, and week 26. RESULTS In the study, 465 children (58.1%) completed all assessments. The achieved differences between the GI and protein groups were 2.3 GI U and 4.9 protein percentage points, respectively. The LP/HGI group increased body fat percentage significantly more than the other groups (P = .040; partial η(2) = 0.039), and the percentage of overweight/obese children in the HP/LGI group decreased significantly during the intervention (P = .031). CONCLUSIONS Neither GI nor protein had an isolated effect on body composition. However, the LP/HGI combination increased body fat, whereas the HP/LGI combination was protective against obesity in this sample of children.
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Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes.
Sievenpiper, JL, Kendall, CW, Esfahani, A, Wong, JM, Carleton, AJ, Jiang, HY, Bazinet, RP, Vidgen, E, Jenkins, DJ
Diabetologia. 2009;(8):1479-95
Abstract
AIMS/HYPOTHESIS Dietary non-oil-seed pulses (chickpeas, beans, peas, lentils, etc.) are a good source of slowly digestible carbohydrate, fibre and vegetable protein and a valuable means of lowering the glycaemic-index (GI) of the diet. To assess the evidence that dietary pulses may benefit glycaemic control, we conducted a systematic review and meta-analysis of randomised controlled experimental trials investigating the effect of pulses, alone or as part of low-GI or high-fibre diets, on markers of glycaemic control in people with and without diabetes. METHODS We searched MEDLINE, EMBASE, CINAHL, and the Cochrane Library for relevant controlled trials of >or=7 days. Two independent reviewers (A. Esfahani and J. M. W. Wong) extracted information on study design, participants, treatments and outcomes. Data were pooled using the generic inverse variance method and expressed as standardised mean differences (SMD) with 95% CIs. Heterogeneity was assessed by chi (2) and quantified by I (2). Meta-regression models identified independent predictors of effects. RESULTS A total of 41 trials (39 reports) were included. Pulses alone (11 trials) lowered fasting blood glucose (FBG) (-0.82, 95% CI -1.36 to -0.27) and insulin (-0.49, 95% CI -0.93 to -0.04). Pulses in low-GI diets (19 trials) lowered glycosylated blood proteins (GP), measured as HbA(1c) or fructosamine (-0.28, 95% CI -0.42 to -0.14). Finally, pulses in high-fibre diets (11 trials) lowered FBG (-0.32, 95% CI -0.49 to -0.15) and GP (-0.27, 95% CI -0.45 to -0.09). Inter-study heterogeneity was high and unexplained for most outcomes, with benefits modified or predicted by diabetes status, pulse type, dose, physical form, duration of follow-up, study quality, macronutrient profile of background diets, feeding control and design. CONCLUSIONS/INTERPRETATION Pooled analyses demonstrated that pulses, alone or in low-GI or high-fibre diets, improve markers of longer term glycaemic control in humans, with the extent of the improvements subject to significant inter-study heterogeneity. There is a need for further large, well-designed trials.
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Open-label, randomized, multiple-center, parallel study comparing glycemic responses and safety profiles of Glucerna versus Fresubin in subjects of type 2 diabetes mellitus.
Wang, WQ, Zhang, YF, Zhou, DJ, Liu, ZM, Hong, X, Qiu, MC, Shi, YQ, Xia, PJ, Lu, J, Xu, MJ, et al
Endocrine. 2008;(1):45-52
Abstract
Since the increase of prevalence of type 2 diabetes mellitus (T-2DM), the replacing quickly absorbed carbohydrates with a fat source rich in monounsaturated fatty acid to provide improved glycemic control in these patients has become an important assistant therapy. In the present study, we compared glycemic response and safety of two nutritional products, Glucerna and Fresubin, in Chinese subjects with T-2DM. Overall, 203 T-2DM subjects were randomly assigned (1:1) to either Glucerna or Fresubin. The primary endpoint was the adjusted area under the curve (adj-AUC) for plasma glucose at 0-240 min. Blood samples were collected at 0, 30, 60, 90, 120, 180, and 240 min to compare the adjusted area under the curve (AUC) for the change in plasma glucose or insulin from 0 to 240 min. Adjusted peak values and times of glucose and insulin responses and adjusted glucose and insulin values were collected at the same time points. Safety parameters were also evaluated. The adjusted AUC for the change in plasma glucose in the Glucerna group was significantly lower than in Fresubin group (5.60 +/- 5.88 mmol/l*h vs. 7.97 +/- 6.32 mmol/l*h, P = 0.0061), as was the adjusted peak value of glucose (3.51 +/- 2.04 mmol/l vs. 4.69 +/- 1.99 mmol/l, P < 0.0001). Glucerna subjects had a longer adjusted peak time to insulin response compared to Fresubin subjects (105.00 +/- 43.4 min vs. 88.81 +/- 37.69 min, P = 0.0050). Glucerna subjects also experienced more gradual changes in glucose and insulin values. In conclusion, Glucerna provided better control of postprandial plasma glucose and insulin levels in Chinese subjects with T-2DM. Variation of postprandial glucose tended to be relatively stable after patients took Glucerna. Study results suggest that Glucerna may be beneficial in the reduction of postprandial glycemia.