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Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.
Huo, J, Liu, LS, Jian, WY, Zeng, JP, Duan, JG, Lu, XJ, Yin, S
Chinese journal of integrative medicine. 2018;(10):728-733
Abstract
BACKGROUND Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. OBJECTIVE To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. METHODS This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. CONCLUSION This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).
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Musculoskeletal complications in type 1 diabetes.
Larkin, ME, Barnie, A, Braffett, BH, Cleary, PA, Diminick, L, Harth, J, Gatcomb, P, Golden, E, Lipps, J, Lorenzi, G, et al
Diabetes care. 2014;(7):1863-9
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OBJECTIVE The development of periarticular thickening of skin on the hands and limited joint mobility (cheiroarthropathy) is associated with diabetes and can lead to significant disability. The objective of this study was to describe the prevalence of cheiroarthropathy in the well-characterized Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort and examine associated risk factors, microvascular complications, and the effect of former DCCT therapy (intensive [INT] vs. conventional [CONV]) on its development. RESEARCH DESIGN AND METHODS This cross-sectional analysis was performed in 1,217 participants (95% of the active cohort) in EDIC years 18/19 after an average of 24 years of follow-up. Cheiroarthropathy-defined as the presence of any one of the following: adhesive capsulitis, carpal tunnel syndrome, flexor tenosynovitis, Dupuytren's contracture, or a positive prayer sign-was assessed using a targeted medical history and standardized physical examination. A self-administered questionnaire (Disabilities of the Arm, Shoulder and Hand [DASH]) assessed functional disability. RESULTS Cheiroarthropathy was present in 66% of subjects (64% of the INT group and 68% of the CONV group; P = 0.1640) and was associated with age, sex, diabetes duration, skin intrinsic fluorescence, HbA1c, neuropathy, and retinopathy (P < 0.005 for each). DASH functional disability scores were worse among subjects with cheiroarthropathy (P < 0.0001). CONCLUSIONS Cheiroarthropathy is common in people with type 1 diabetes of long duration (∼30 years) and is related to longer duration and higher levels of glycemia. Clinicians should include cheiroarthropathy in their routine history and physical examination of patients with type 1 diabetes because it causes clinically significant functional disability.
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Effect of early multifactorial therapy compared with routine care on microvascular outcomes at 5 years in people with screen-detected diabetes: a randomized controlled trial: the ADDITION-Europe Study.
Sandbæk, A, Griffin, SJ, Sharp, SJ, Simmons, RK, Borch-Johnsen, K, Rutten, GE, van den Donk, M, Wareham, NJ, Lauritzen, T, Davies, MJ, et al
Diabetes care. 2014;(7):2015-23
Abstract
OBJECTIVE To determine the benefit of multifactorial treatment on microvascular complications among people with type 2 diabetes detected by screening. RESEARCH DESIGN AND METHODS This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level. In four centers in Denmark; Cambridge, U.K.; the Netherlands; and Leicester, U.K., 343 general practices participated in the trial. Eligible for follow-up were 2,861 of the 3,057 people with diabetes detected by screening included in the original trial. Biomedical data on nephropathy were collected in 2,710 (94.7%) participants, retinal photos in 2,190 (76.6%), and questionnaire data on peripheral neuropathy in 2,312 (80.9%). The prespecified microvascular end points were analyzed by intention to treat. Results from the four centers were pooled using fixed-effects meta-analysis. RESULTS Five years after diagnosis, any kind of albuminuria was present in 22.7% of participants in the intensive treatment (IT) group and in 24.4% in the routine care (RC) group (odds ratio 0.87 [95% CI 0.72-1.07]). Retinopathy was present in 10.2% of the IT group and 12.1% of the RC group (0.84 [0.64-1.10]), and severe retinopathy was present in one patient in the IT group and seven in the RC group. Neuropathy was present in 4.9% and 5.9% (0.95 [0.68-1.34]), respectively. Estimated glomerular filtration rate increased between baseline and follow-up in both groups (4.31 and 6.44 mL/min, respectively). CONCLUSIONS Compared with RC, an intervention to promote target-driven, intensive management of patients with type 2 diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at 5 years.
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Comparative effectiveness of renin-angiotensin system blockers and other antihypertensive drugs in patients with diabetes: systematic review and bayesian network meta-analysis.
Wu, HY, Huang, JW, Lin, HJ, Liao, WC, Peng, YS, Hung, KY, Wu, KD, Tu, YK, Chien, KL
BMJ (Clinical research ed.). 2013;:f6008
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OBJECTIVE To assess the effects of different classes of antihypertensive treatments, including monotherapy and combination therapy, on survival and major renal outcomes in patients with diabetes. DESIGN Systematic review and bayesian network meta-analysis of randomised clinical trials. DATA SOURCES Electronic literature search of PubMed, Medline, Scopus, and the Cochrane Library for studies published up to December 2011. STUDY SELECTION Randomised clinical trials of antihypertensive therapy (angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), α blockers, β blockers, calcium channel blockers, diuretics, and their combinations) in patients with diabetes with a follow-up of at least 12 months, reporting all cause mortality, requirement for dialysis, or doubling of serum creatinine levels. DATA EXTRACTION Bayesian network meta-analysis combined direct and indirect evidence to estimate the relative effects between treatments as well as the probabilities of ranking for treatments based on their protective effects. RESULTS 63 trials with 36,917 participants were identified, including 2400 deaths, 766 patients who required dialysis, and 1099 patients whose serum creatinine level had doubled. Compared with placebo, only ACE inhibitors significantly reduced the doubling of serum creatinine levels (odds ratio 0.58, 95% credible interval 0.32 to 0.90), and only β blockers showed a significant difference in mortality (odds ratio 7.13, 95% credible interval 1.37 to 41.39). Comparisons among all treatments showed no statistical significance in the outcome of dialysis. Although the beneficial effects of ACE inhibitors compared with ARBs did not reach statistical significance, ACE inhibitors consistently showed higher probabilities of being in the superior ranking positions among all three outcomes. Although the protective effect of an ACE inhibitor plus calcium channel blocker compared with placebo was not statistically significant, the treatment ranking identified this combination therapy to have the greatest probability (73.9%) for being the best treatment on reducing mortality, followed by ACE inhibitor plus diuretic (12.5%), ACE inhibitors (2.0%), calcium channel blockers (1.2%), and ARBs (0.4%). CONCLUSIONS Our analyses show the renoprotective effects and superiority of using ACE inhibitors in patients with diabetes, and available evidence is not able to show a better effect for ARBs compared with ACE inhibitors. Considering the cost of drugs, our findings support the use of ACE inhibitors as the first line antihypertensive agent in patients with diabetes. Calcium channel blockers might be the preferred treatment in combination with ACE inhibitors if adequate blood pressure control cannot be achieved by ACE inhibitors alone.
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Area-under-the-HbA1c-curve above the normal range and the prediction of microvascular outcomes: an analysis of data from the Diabetes Control and Complications Trial.
Maple-Brown, LJ, Ye, C, Retnakaran, R
Diabetic medicine : a journal of the British Diabetic Association. 2013;(1):95-9
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AIMS: In the Diabetes Control and Complications Trial, mean updated HbA(1c) accounted for most of the differential risk of microvascular complications between intensive and conventional insulin therapy. We hypothesized, however, that a more precise measure of chronic hyperglycaemic exposure may be the incremental area-under-the-HbA(1c)-curve above the Diabetes Control and Complications Trial-standardized normal range for HbA(1c) (iAUC(HbA1c>norm)). METHODS Using the Principal Diabetes Control and Complications Trial data set, we compared the following three measures of chronic glycaemic exposure for their capacity to predict retinopathy, nephropathy and neuropathy during the Diabetes Control and Complications Trial: mean updated HbA(1c), iAUC(HbA1c>norm), and total area-under-the-HbA(1c)-curve (tAUC(HbA1c)). For each outcome, models using each of these three glycaemic measures were compared in the following three ways: hazard or odds ratio, χ(2) statistic, and Akaike information criterion. RESULTS The three glycaemic measures did not differ in their prediction of neuropathy. iAUC(HbA1c>norm) was modestly superior to mean updated HbA(1c) for predicting nephropathy (χ(2) P = 0.017, Akaike P = 0.032). In contrast, for predicting retinopathy, both iAUC(HbA1c>norm) (χ(2) P = 0.0005, Akaike P = 0.0005) and tAUC(HbA1c) (χ(2) P = 0.004, Akaike P = 0.004) were significantly better than mean updated HbA(1c). Varying its HbA(1c) threshold incrementally between 37 and 53 mmol/mol (5.5-7.0%), inclusive, did not improve the prediction of retinopathy by iAUC(HbA1c>threshold) beyond that of tAUC(HbA1c,) consistent with the concept of a continuous relationship between glycaemia and retinopathy, with no glycaemic threshold. CONCLUSIONS Both iAUC(HbA1c>norm) and tAUC(HbA1c) were superior to mean updated HbA(1c) for predicting retinopathy. Optimal assessment of chronic glycaemic exposure as a determinant of retinopathic risk may require consideration of both the degree of hyperglycaemia and its duration.
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Influence of intensive versus conventional glucose control on microvascular and macrovascular complications in type 1 and 2 diabetes mellitus.
Mattila, TK, de Boer, A
Drugs. 2010;(17):2229-45
Abstract
In type 1 and 2 diabetes mellitus patients, hyperglycaemia is independently related to the development of microvascular and macrovascular complications. Glycaemic targets and the benefits of intensive versus conventional glucose control are under debate. The purpose of this review is to provide an overview of the randomized controlled trials and meta-analyses comparing the effects of intensive versus conventional glucose control on microvascular and macrovascular complications in type 1 and 2 diabetes. MEDLINE and Cochrane database searches were performed with a limit on randomized controlled trials or meta-analysis and keywords related to glucose control and diabetes. In addition, related articles and reference lists of relevant articles and guidelines were reviewed. Nine randomized controlled trials, three in type 1 and six in type 2 diabetes, and four meta-analyses in type 2 diabetes were reviewed. These studies included more than 30,000 patients. On the basis of these trials and meta-analyses, it can be concluded that intensive glucose control has a beneficial effect on microvascular complications (retinopathy, nephropathy, neuropathy) in both type 1 and type 2 diabetes patients. The risk reduction of developing a microvascular complication varied between 25% and 76%. Particularly in patients with type 2 diabetes, there was a 10-15% decrease in nonfatal myocardial infarction with intensive glucose control, but no effect on stroke, cardiovascular death or all-cause mortality was observed. There was a beneficial effect of intensive glucose control on cardiovascular disease in patients with type 1 diabetes in only one trial. In all studies, intensive glucose control was associated with at least twice the risk for serious hypoglycaemia than the conventional-control group. In conclusion, compared with conventional glucose control, intensive glucose control is associated with fewer microvascular complications in both type 1 and type 2 diabetes, a decrease in coronary events, especially in type 2 diabetes, and more serious hypoglycaemia.
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[Patogenetic therapy of patients with diabetes mellitus type 2 and cerebral vascular insufficiency].
Kamchatnov, PR, Karalkin, AV, Chugunov, AV, Kabanov, AA, Bassé, DA, Mikhaĭlova, NA, Umarova, KhIa, Boĭko, AN
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. 2008;(3):18-23
Abstract
Effectiveness of halidor preparation was assessed in a randomized open 8-weeks study in 44 patients with diabetes mellitus type 2 and chronic cerebral blood circulation disorders. A control group included 15 patients with the same pathologies who did not receive halidor. Administration of halidor in doses 100 mg 3 times daily led to the improvement of clinical state in 32 (72,7%) patients that was confirmed by statistically better performance (p<0,05) on the neuropsychological tests: MMSE by 14,7%, clock-drawing test by 16,8%, the Schult test by 23,5%. The blood flow in middle and posterior cerebral arteries was increased by 21 and 23%, respectively (p<0,05), and the vascular tonus was reduced. The possibility of halidor administration to patients with diabetes mellitus with concomitant chronic cerebral blood circulation disorders is discussed.
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Valsartan improves arterial stiffness in type 2 diabetes independently of blood pressure lowering.
Karalliedde, J, Smith, A, DeAngelis, L, Mirenda, V, Kandra, A, Botha, J, Ferber, P, Viberti, G
Hypertension (Dallas, Tex. : 1979). 2008;(6):1617-23
Abstract
Increased arterial stiffness, as estimated from aortic pulse wave velocity (Ao-PWV), and albuminuria are independent predictors for cardiovascular disease in type 2 diabetes mellitus (T2DM). Whether angiotensin receptor blockers (ARBs), drugs with cardio-renal protective effects, improve Ao-PWV to a greater extent than other equipotent antihypertensive medications remains unclear. After a 4-week washout phase, we compared the effects of valsartan (n=66), an ARB, with that of amlodipine (n=65), a calcium channel blocker on Ao-PWV in 131 T2DM patients with pulse pressure (PP) >or=60 mm Hg and raised albumin excretion rate (AER) in a 24-week randomized, double-blind, parallel group study. Hydrochlorothiazide (HCTZ) 25 mg/d was added to valsartan 160 mg and amlodipine 5 mg/od uptitrated to 10 mg/od after 4 weeks to ensure equivalent BP control. After 24 weeks brachial and central aortic PP had fallen to a similar extent with attained mean (SD) brachial and central PP of 61.6 (13.6) and 47.3 (14.1) mm Hg in the valsartan/HCTZ group and 61.5 (12.2) and 47.3 (9.9) mm Hg in the amlodipine group, respectively. Ao-PWV showed a significantly greater reduction, mean (95% CI), -0.9 m/s (-1.4 to -0.3) for valsartan/HCTZ compared to amlodipine (P=0.002). AER fell significantly only with Val/HCTZ from 30.8(20.4, 46.5) to 18.2(12.5, 26.3) mcg/min, (P=0.01) with between treatment difference in favor of Val/HCTZ of -15.3mcg/min (P<0.001). Changes in AER and Ao-PWV were not correlated. Valsartan/HCTZ improves arterial stiffness and AER to a significantly greater extent than amlodipine despite similar central and brachial BP control. These 2 effects, which appear independent of each other, may explain the specific cardio-renal protective properties of ARBs.
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[Dual cholesterol inhibition. More high risk patients achieve LDL cholesterol values below 100 mg/dl].
MMW Fortschritte der Medizin. 2008;(23):39
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[Clinical trial of the month. ADVANCE: improved survival and better vascular and renal outcomes with a fixed combination of perindopril and indapamide in patients with type 2 diabetes].
Scheen, AJ, Krzesinski, JM
Revue medicale de Liege. 2007;(10):639-43
Abstract
The controlled ADVANCE trial compared the incidence of major macrovascular and microvascular complications in 5,569 type 2 diabetic patients randomised to a fixed combination of perindopril and indapamide and in 5,571 patients randomised to placebo, followed for a mean duration of 4.3 years. Compared with patients assigned placebo, those assigned active therapy had a mean reduction in systolic blood pressure of 5.6 mm Hg and diastolic blood pressure of 2.2 mm Hg, despite the fact physicians were allowed to adjust antihypertensive therapy ad libitum. The relative risk of a major macrovascular and microvascular event (primary endpoint) was reduced by 9% (p = 0.041) in the active group. The separate reductions in macrovascular and microvascular events were similar but were not independently statistically significant. The relative risk of death was significantly reduced by 14% (p = 0.025), essentially due to a lower death rate from cardiovascular diseases (-18%; p = 0.027). The incidence of any coronary event was also significantly reduced (-14 %; p = 0.020), while only a trend was observed for all cerebrovascular events. Finally, renal events were significantly less frequent (-21%; p < 0.0001) whereas all ocular events were only slightly reduced (-5%; NS) in the active group as compared to the placebo group. The fixed combination of perindopril and indapamide was well tolerated and easy to administer. Overall one death due to any cause would be averted among every 79 diabetic patients assigned active therapy for 5 years. There was no evidence that the effects of the study treatment differed by initial blood pressure level or concomitant use of other treatments at baseline.