UMIN-CTR Clinical Trial

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

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

HbA1c at first visit

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Institute for Adult Diseases, Asahi Life Foundation

Institute

Department

Personal name

Organization

The Institute for Adult Diseases, Asahi Life Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

06

Month

06

Day

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pubmed/24843707

Publication of results

Published

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

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 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.

Registered date

2011

Year

06

Month

06

Day

Last modified on

2016

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006770