Long‐term multiple risk factor interventions in Japanese elderly diabetic patients: The Japanese Elderly Diabetes Intervention Trial – study design, baseline characteristics and effects of intervention

Abstract

Aim:To evaluate long-term, multiple risk factor intervention on physical, psychological and mental prognosis, and development of complications and cardiovascular disease in elderly type 2 diabetes patients. Methods:Our randomized, controlled, multicenter, prospective intervention trial included 1173 elderly type 2 diabetes patients who were enrolled from 39 Japanese institutions and randomized to an intensive or conservative treatment group. Glycemic control, dyslipidemia, hypertension, obesity, diabetic complications and atherosclerotic disease were measured annually. Instrumental activity of daily living, cognitive impairment, depressive symptoms and diabetes burden were assessed at baseline and 3 years. Results: There was no significant difference in clinical or cognitive parameters at baseline between the two groups. The prevalence of low activities of daily living, depressive symptoms and cognitive impairment was 13%, 28% and 4%, respectively, and was similar in the two groups. A small, but significant difference in HbA1c between the two groups was observed at 1 year after the start of intervention (7.9% vs 8.1%, P < 0.05), although this significant difference was not observed after the second year. With the exception of coronary revascularization, there was no significant difference in fatal or non-fatal events between the two groups. Composite events were also similar in the two groups.Conclusions: This study showed no significant differences in fatal or non-fatal events between intensive and conventional treatment. The present study might clarify whether treatment of risk factors influences function and quality of life in elderly diabetic patients.

Dietary pattern and mortality in Japanese elderly patients with type 2 diabetes mellitus: Does a vegetable‐ and fish‐rich diet improve mortality? An explanatory study

“…Although the study design for the J-EDIT was a randomized control study by two groups, in which elderly diabetes patients were randomly allocated to standard therapy or intensive therapy, 12 there was no significant difference in the distribution of dietary patterns in the two groups (data not shown); therefore, we combined the two groups and analyzed them as a single cohort in the present.…”

“…The study design and the details of J-EDIT are described in the article by Araki et al 12 in the present issue of the journal, and the details of the questionnaire for the nutritional survey are described in the article by Yoshimura et al 13 and Kamada et al 14 Following is a brief outline of the study: J-EDIT studied elderly type 2 diabetes patients, randomizing them to standard therapy or intensive therapy. It was a prospective randomized controlled trial that followed the patients for 6 years.…”

“…After the sixth year of follow up, the drop-out rate was 8.9%, 12 but considering that the participants are elderly, the follow-up rate is excellent (death is treated as a cut-off in the calculation for the drop-out rate).…”

Effective prevention of cardiovascular disease and diabetes‐related events with atorvastatin in Japanese elderly patients with type 2 diabetes mellitus: Adjusting for treatment changes using a marginal structural proportional hazards model and a rank‐preserving structural failure time model

“…24 Briefly, the J-EDIT was launched in 2001 as a prospective, randomized, controlled intervention trial of Japanese elderly people with type 2 diabetes mellitus for the purpose of determining how to prevent several diabetic complications. Between March 2001 and February 2002, the study enrolled diabetic patients from 39 hospitals in Japan who had met the following eligibility criteria: having type 2 diabetes mellitus; being aged 65-84 years; and having serum glycated hemoglobin A1c (HbA1c) levels of 7.9% or more or 7.4-7.8% with at least one of the comorbidities, including (pre)hypertension (systolic/diastolic blood pressure [BP] more than 130/85 mmHg), obesity (body mass index [BMI] of 25 kg/m 2 or more) or dyslipidemia (total cholesterol of 200 mg/dL or more, or LDL cholesterol of 120 mg/dL or more for patients without a history of ischemic heart disease; total cholesterol of 180 mg/dL or more, or LDL cholesterol of 100 mg/dL or more for patients with ischemic heart disease; high-density lipoprotein [HDL] cholesterol of less than 40 mg/dL; or triglyceride levels of 150 mg/dL or more).…”

“…Target levels were not defined for the conventional treatment group. 24 In the intensive treatment group, the study protocol recommended the use of atorvastatin when control of total cholesterol and LDL cholesterol levels failed.…”