Diabetes
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We investigated familial clustering of diabetic retinopathy and nephropathy in the families of 372 subjects from the Diabetes Control and Complications Trial (DCCT). These subjects had 467 first-degree relatives with IDDM or NIDDM. Family sizes ranged from two to six. ⋯ None of these correlations is statistically significant. The lack of significant correlation for the severity of nephropathy may reflect the relatively short duration of diabetes in the offspring of these families and the known high intrasubject variability of AERs. These data provide the first available evidence that the severity of diabetic retinopathy is influenced by familial (possibly genetic) factors and confirmatory evidence that such factors influence the development
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Review Randomized Controlled Trial Multicenter Study Clinical Trial
Alpha-lipoic acid in the treatment of diabetic peripheral and cardiac autonomic neuropathy.
Antioxidant treatment has been shown to prevent nerve dysfunction in experimental diabetes, providing a rationale for a potential therapeutic value in diabetic patients. The effects of the antioxidant alpha-lipoic acid (thioctic acid) were studied in two multicenter, randomized, double-blind placebo-controlled trials. In the Alpha-Lipoic Acid in Diabetic Neuropathy Study, 328 patients with NIDDM and symptomatic peripheral neuropathy were randomly assigned to treatment with intravenous infusion of alpha-lipoic acid using three doses (ALA 1,200 mg; 600 mg; 100 mg) or placebo (PLAC) over 3 weeks. ⋯ A trend toward a favorable effect of ALA was noted for the remaining two indexes. In both studies, no significant adverse events were observed. In conclusion, intravenous treatment with alpha-lipoic acid (600 mg/day) over 3 weeks is safe and effective in reducing symptoms of diabetic peripheral neuropathy, and oral treatment with 800 mg/day for 4 months may improve cardiac autonomic dysfunction in NIDDM.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial.
The Diabetes Control and Complications Trial (DCCT) demonstrated a reduction in the development and progression of the long-term complications of IDDM with intensive therapy aimed at achieving glycemic control as close to the nondiabetic range as possible. The DCCT subsequently showed that the total lifetime exposure to glycemia was the principal determinant of the risk of retinopathy and that there was a continuous nonlinear relationship between this risk and the mean level of HbA1c (DCCT Research Group, Diabetes 44:968-993, 1995). In contrast, other authors, based on a retrospective study (Krolewski et al., N Engl J Med 332:1251-1255, 1995), have suggested that a glycemic threshold for microabuminuria and for retinopathy exists at an HbA1c level of approximately 8%, below which there is no further appreciable reduction in risk. ⋯ These extensive prospective DCCT data do not support the conjecture that a glycemic threshold for the development of complications exists at an HbA1c of 8% or that an HbA1c goal of 8% is maximally beneficial. In the DCCT, as HbA1c was reduced below 8% there were continuing relative reductions in the risk of complications, whereas there was a slower rate of increase in the risk of hypoglycemia. Therefore, the DCCT continues to recommend implementation of intensive therapy with the goal of achieving normal glycemia as early as possible in as many IDDM patients as is safely possible.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group.
The objective of the U. K. Prospective Diabetes Study is to determine whether improved blood glucose control in type II diabetes will prevent the complications of diabetes and whether any specific therapy is advantageous or disadvantageous. ⋯ Of all subjects, 18.0% had suffered one or more diabetes-related clinical endpoints, with 12.1% having a macrovascular and 5.7% a microvascular endpoint. Sulfonylurea, metformin, and insulin therapies were similarly effective in improving glucose control compared with a policy of diet therapy. The study is examining whether the continued improved glucose control, obtained by intensive therapy compared with conventional therapy (median over 6 years HbA1c 6.6% compared with 7.4%), will be clinically advantageous in maintaining health.
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Multicenter Study Comparative Study Clinical Trial Controlled Clinical Trial
The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial.
The Diabetes Control and Complications Trial (DCCT) demonstrated that a regimen of intensive therapy aimed at maintaining near-normal blood glucose values markedly reduces the risks of development or progression of retinopathy and other complications of insulin-dependent diabetes mellitus (IDDM) when compared with a conventional treatment regimen. This report presents an epidemiological assessment of the association between levels of glycemic exposure (HbA1c) before and during the DCCT with the risk of retinopathy progression within each treatment group. The initial level of HbA1c observed at eligibility screening as an index of pre-DCCT glycemia and the duration of IDDM on entry were the dominant baseline predictors of the risk of progression. ⋯ When examined simultaneously within each treatment group, each of the components of pre-DCCT glycemic exposure (screening HbA1c value and IDDM duration) and glycemic exposure during the DCCT (mean HbA1c, time in study, and their interaction) were significantly associated with risk of retinopathy progression. Similar results also apply to other retinopathic, nephropathic, and neuropathic outcomes. The recommendation of the DCCT remains that intensive therapy with the goal of achieving near-normal glycemia should be implemented as early as possible in as many IDDM patients as is safely possible.