Strict Glycemic Control Ameliorates the Increase of Carotid IMT in Patients with Type 2 Diabetes

Kawasumi, Masahiko; Tanaka, Yasushi; Uchino, Hiroshi; Shimizu, Tomoaki; Tamura, Yasuaki; Sato, Fumihiko; Mita, Tomoya; Watada, Hirotaka; Sakai, Ken; Hirose, Takahisa; Kawamori, Ryuzo

doi:10.1507/endocrj.53.45

Cited by 31 publications

(17 citation statements)

References 21 publications

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“…However, this study excluded patients with T2DM. Previous reports have also shown that it takes approximately 3 to 5 years to observe visible changes in the carotid IMT in T2DM patients receiving multi factor intensive treatment (30,31). However, according to the study by Higgins (32), obvious changes in the carotid IMT may be observed as early as one year after allopurinol treatment.…”

Section: Discussionmentioning

confidence: 93%

The Effects of Allopurinol on the Carotid Intima-media Thickness in Patients with Type 2 Diabetes and Asymptomatic Hyperuricemia: A Three-year Randomized Parallel-controlled Study

et al. 2015

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Objective The aim of this study was to investigate the long-term effective control of serum uric acid by allopurinol on the carotid intima-media thickness (IMT) in patients with type 2 diabetes (T2DM) and asymptomatic hyperuricemia (HUA). Methods This was a randomized open parallel-controlled study. In this study, 176 patients with T2DM and asymptomatic HUA were randomly allocated to the conventional or allopurinol treatment groups on the basis of a computer-generated random number table. Changes in the carotid IMT, biochemical indexes, high sensitive C-reactive protein (hs-CRP) and the incidence of hypertension in patients before and after three years of treatment were examined and compared between the groups. Results There were no statistically significant differences in the baseline characteristics of the study participants between the two treatment groups (p>0.05 for all). Nevertheless, the serum uric acid, triglyceride, and hs-CRP levels and the homeostasis assessment for insulin resistance (HOMA-IR), systolic blood pressure, diastolic blood pressure and the carotid IMT in the allopurinol group were significantly lower than those in the conventional group after three years of treatment (p<0.01 for all). The intention-to-treat analysis indicated that the incidence of new-onset hypertension in the allopurinol group showed a declining trend compared to that in the conventional treatment group (6.8% vs. 13.6%, p>0.05). Conclusion The long-term effective control of serum uric acid by allopurinol may improve insulin resistance, decrease the serum levels of hs-CRP, reduce the carotid IMT, and may delay the development of atherosclerosis in patients with T2DM and asymptomatic HUA.

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Section: Discussionmentioning

confidence: 93%

The Effects of Allopurinol on the Carotid Intima-media Thickness in Patients with Type 2 Diabetes and Asymptomatic Hyperuricemia: A Three-year Randomized Parallel-controlled Study

et al. 2015

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“…Nevertheless, it must be stressed that clinical trials convincingly demonstrating a direct relationship between reduction in PPG and improvement in patient-important endpoints are not yet available. Several trials in patients with type 1 or type 2 diabetes demonstrated the favorable effect of PPG reduction on the intima-media complex thickness (IMT) [22][23][24]. IMT cannot, however, be considered to be a clear patientimportant endpoint, although its correlation with the incidence of cardiovascular events (stroke, myocardial infarction and others) has been described in several studies that included non-diabetic subjects [25][26][27].…”

Section: Surrogate Endpoints In Diabetic Studiesmentioning

confidence: 99%

The Role of Surrogate Endpoints in the Evaluation of Efficacy and Safety of Therapeutic Interventions in Diabetes Mellitus

Wieczorek¹,

Rys²,

Skrzekowska-Baran³

et al. 2008

Rev Diabet Stud

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■ AbstractIn this paper, we examine the concept of surrogate endpoints (i.e. substitute outcome measures) and review their use in clinical trials involving therapies for diabetes mellitus using the example of metformin. Trials such as DCCT and UKPDS, in which patient-important endpoints were evaluated, are relatively rare in diabetology. Clinical decisions, therefore, are often based on evidence obtained using surrogate outcomes, usually fasting or postprandial glycemia or glycated hemoglobin level. In contrast to patient-important endpoints, surrogates do not describe direct clinical benefit to the patient. However, a proven association between a surrogate and patient-important endpoint is essential to draw appropriate therapeutic conclusions. In the process of new drug development, the duration of follow-up, sample size and methodology of the studies initially available are often inadequate to demonstrate the effect of the intervention on patient-important endpoints. Evidence concerning the effect of an intervention on surrogate outcomes usually comes first, followed only later by reports describing its influence on patient-important endpoints. Metformin may serve as an example in several ways. The first publications reported beneficial effects on glycemic control and body weight. Outcomes from the subsequent UKPDS study suggested the patient-important efficacy of metformin measured as a reduction in mortality and a decrease in the incidence of diabetic complications, including myocardial infarction. This reasoning process worked for some but not all strategies. It is particularly questionable whether a change in surrogate endpoint was associated with a potential deterioration in patient-important outcomes. Defining the general relationship between surrogates widely used as measures of metabolic control and patient-important endpoints remains an important challenge in contemporary diabetology. Vocabulary of endpoints description in clinical trialsnderstanding and interpreting the methodology and results of clinical studies requires familiarity with a wide range of terms and definitions which, if not used carefully, may be difficult or confusing for the reader of clinical literature. The different concepts associated with describing an endpoint may serve as an example. An endpoint (or an outcome) is any measurable effect (usually, but not necessarily, related to health) observed in individuals participating in a clinical trial. The effect of an external factor (for example, tobacco smoking as predictive factor or a prophylactic cholesterol lowering drug as therapeutic factor) on this kind of selected endpoint is investigated in

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“…Thus, it is not only used to determine whether a patient's metabolic control has reached and been maintained within the target range, but also to estimate the risk of chronic diabetic complications in each patient [2,3]. However, HbA1c may not be suitable for the evaluation of shortterm variations of glycemic control because of the long lifespan of erythrocytes (120 days).…”

mentioning

confidence: 99%

Comparison of Glycated Albumin (GA) and Glycated Hemoglobin (HbA1c) in Type 2 Diabetic Patients: Usefulness of GA for Evaluation of Short-term Changes in Glycemic Control

et al. 2007

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Abstract. We studied the cross-sectional relationship between GA and HbA1c in 142 type 2 diabetic patients who had an HbA1c level <7.5% for at least one year without fluctuation by more than 0.5%. We also followed the changes of GA and HbA1c in 18 type 2 diabetic patients for 16 weeks as they progressed from untreated severe hyperglycemia (HbA1c≥9.0%) to good glycemic control (HbA1c≤6.5%) by intensive insulin treatment. The annual mean levels of GA and HbA1c in the stably controlled patients showed a weak, but significant, correlation (r = 0.23, p<0.001) in the 142 diabetic patients. However, the GA/HbA1c ratio ranged widely from 2.0 to 4.0 showing a normal distribution (2.9 ± 0.34, M ± SE), although patients with conditions affecting albumin turnover or RBC lifespan were excluded from the study. The GA/HbA1c ratio was significantly higher when patients were in hyperglycemic than when glycemic control was good (3.5 ± 0.15 vs. 2.9 ± 0.07, M ± SE, p<0.01). GA decreased more rapidly than HbA1c during intensive insulin therapy, but the percent reduction of HbA1c eventually corresponded with that of GA by 16 weeks after the start of treatment. These results demonstrate that, although unknown influences on GA or HbA1c may exist, GA may be a useful marker for monitoring short-term variations of glycemic control during treatment of diabetic patients.

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Strict Glycemic Control Ameliorates the Increase of Carotid IMT in Patients with Type 2 Diabetes

Cited by 31 publications

References 21 publications

The Effects of Allopurinol on the Carotid Intima-media Thickness in Patients with Type 2 Diabetes and Asymptomatic Hyperuricemia: A Three-year Randomized Parallel-controlled Study

The Effects of Allopurinol on the Carotid Intima-media Thickness in Patients with Type 2 Diabetes and Asymptomatic Hyperuricemia: A Three-year Randomized Parallel-controlled Study

The Role of Surrogate Endpoints in the Evaluation of Efficacy and Safety of Therapeutic Interventions in Diabetes Mellitus

Comparison of Glycated Albumin (GA) and Glycated Hemoglobin (HbA1c) in Type 2 Diabetic Patients: Usefulness of GA for Evaluation of Short-term Changes in Glycemic Control

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