Evidence map›Paper›PMID 20054522›Full record

Trial reportDiabetologia2010

Long-term lifestyle intervention lowers the incidence of stroke in Japanese patients with type 2 diabetes: a nationwide multicentre randomised controlled trial (the Japan Diabetes Complications Study).

H Sone, S Tanaka, S Iimuro, S Tanaka, K Oida, Y Yamasaki, S Oikawa, S Ishibashi, S Katayama, H Yamashita and 6 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02341690 (The Effectiveness of Smartphone Delivered Interval Walking Training on Physical Activity and Glycemic Control in Patients With Type 2 Diabetes), which is not on this map. Cited by 70 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 14 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02341690 nacompletednot on this mapstarted 2015, after this paper: background citation

The Effectiveness of Smartphone Delivered Interval Walking Training on Physical Activity and Glycemic Control in Patients With Type 2 Diabetes: a Pragmatic Randomized Controlled Trial - Part of The InterWalk Study

TypeinterventionalSponsorUniversity of CopenhagenRan2015 to 2017Enrolled226ConditionsDiabetes Mellitus, Type 2ArmsInterval walking training, control
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  3. Blood pressure control for diabetic retinopathy.The Cochrane database of systematic reviews · 2023
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  12. Blood pressure control for diabetic retinopathy.The Cochrane database of systematic reviews · 2015
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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

H SoneDepartment of Internal Medicine, University of Tsukuba Institute of Clinical Medicine, 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan.
S Tanaka
S Iimuro
S Tanaka
K Oida
Y Yamasaki
S Oikawa
S Ishibashi
S Katayama
H Yamashita
H Ito
Y Yoshimura
Y Ohashi
Y Akanuma
N Yamada
Japan Diabetes Complications Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes.

methodsA total of 2,033 eligible Japanese men and women aged 40-70 years with type 2 diabetes from 59 institutes were randomised to a conventional treatment group (CON), which continued to receive the usual care, and a lifestyle intervention group (INT), which received education on lifestyle modification regarding dietary habits, physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit, in addition to the usual care. Randomisation and open-label allocation were done by a central computer system. Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period.

resultsAlthough status of control of most classic cardiovascular risk factors, including body weight, glycaemia, serum lipids and BP, did not differ between groups during the study period, the incidence of stroke in the INT group (5.48/1,000 patient-years) was significantly lower than in the CON group (9.52/1,000 patient-years) by Kaplan- Meier analysis (p=0.02 by logrank test) and by multivariate Cox analysis (HR 0.62, 95% CI 0.39-0.98, p=0.04). The incidence of CHD, retinopathy and nephropathy did not differ significantly between groups. Lipoprotein(a) was another significant independent risk factor for stroke. CONCLUSIONS/

interpretationThese findings suggest that lifestyle modification had limited effects on most typical control variables, but did have a significant effect on stroke incidence in patients with established type 2 diabetes. CLINICAL

trial registrationUMIN-CTR C000000222

fundingThe Ministry of Health, Labour and Welfare, Japan

Indexed as

Life StyleAdultAgedDiabetes ComplicationsDiabetes Mellitus, Type 2DietFemaleHumansIncidenceJapanMaleMiddle AgedQuality of LifeStrokeTreatment Outcome

Identifiers

PMID20054522
PMCPMC2815795

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.