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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005725
Receipt No. R000006770
Scientific Title A 20-year trend of clinical characteristics in patients with type 2 diabetes at first diagnosis in urban Japan
Date of disclosure of the study information 2011/06/06
Last modified on 2016/07/06

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Basic information
Public title A 20-year trend of clinical characteristics in patients with type 2 diabetes at first diagnosis in urban Japan
Acronym A 20-year trend of clinical characteristics in patients with type 2 diabetes at first diagnosis in urban Japan
Scientific Title A 20-year trend of clinical characteristics in patients with type 2 diabetes at first diagnosis in urban Japan
Scientific Title:Acronym A 20-year trend of clinical characteristics in patients with type 2 diabetes at first diagnosis in urban Japan
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cross-sectional study of patients with type 2 diabetes at first diagnosis
Basic objectives2 Others
Basic objectives -Others To investigate two competing hypotheses regarding Japan in the last 20 years: (1) increasing obesity is associated with poor glycemic control in type 2 diabetic patients at the first hospital visit, and (2) a shorter untreated duration of type 2 diabetes at first hospital visit is associated with better glycemic control.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c at first visit
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with untreated type 2 diabetes at the time of their first visit to the Institute for Adult Diseases, Asahi Life Foundation (also called Marunouchi Hospital)
(groupA)in 1986 and 1987
(groupB)in 1996 and 1997
(groupC)from 2006 through 2008
The Japanese diabetic criteria circa 1999 were employed as the diagnostic criteria: fasting plasma glucose >=126 mg/dl, casual plasma glucose >=200 mg/dl, and/or HbA1c (JDS) >=6.5%(HbA1c-NGSP >=6.9%)
Key exclusion criteria None
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Kushiyama
Organization The Institute for Adult Diseases, Asahi Life Foundation
Division name Metabolic Diseases
Zip code
Address 1-6-1, Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL 03-3639-5501
Email kusiyaa-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kushiyama Akifumi
Organization The Institute for Adult Diseases, Asahi Life Foundation
Division name Metabolic Diseases
Zip code
Address 2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo, Japan
TEL 03-3201-6781
Homepage URL http://www.asahi-life.or.jp
Email kusiyaa-tky@umin.ac.jp

Sponsor
Institute The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department

Funding Source
Organization The Institute for Adult Diseases, Asahi Life Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 06 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/24843707
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24843707
Number of participants that the trial has enrolled
Results
Aims/Introduction
To investigate trends over the past 20 years for the prevalence of obesity and glycemic control in association with a patient's first hospital visit for type 2 diabetes mellitus.
Materials and Methods
This was a historical, cross-sectional, time-series, single-center study carried out at Marunouchi Hospital. Data from type 2 diabetic patients who were never treated until their first hospital visit were analyzed for the following periods: 1986-1987 (group A, n = 453), 1996-1997 (group B, n = 547) and 2006-2008 (group C, n = 443). Data on each patient's body mass index (BMI), age, untreated duration and glycated hemoglobin levels were also collected.
Results
Obesity in younger patients (below age 40 years and ages 40-49 years in group C) with poor glycemic control increased over time. Patients with a BMI of <21.0 kg/m2 or >=23.0 kg/m2 showed worse glycemic control than those with a BMI of 21.0-23.0 kg/m2 in group C. Younger patients had worse glycemic control and shorter untreated durations in group C. A BMI >=23.0 kg/m2 was an independent risk factor for glycated hemoglobin levels >=8.4% in group C, even after correction for sex, age, untreated duration and symptoms.
Conclusions
In recent years, glycemic control has worsened in young, obese patients in urban Japan. Obesity is rapidly increasing in younger patients, and patients with a BMI >=23.0 kg/m2 might be candidates for diabetes screening. This trial was registered with the University Medical Information Network Clinical Trials Registry (no. UMIN000005725).

Keywords: Body mass index, Glycated hemoglobin, Screening criteria
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data from patients with untreated type 2 diabetes at the time of their first visit to the Institute for Adult Diseases, Asahi Life Foundation were extracted and registered.

Management information
Registered date
2011 Year 06 Month 06 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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