UMIN-ICDS Clinical Trial

Public title

Follow-up Study of the Asahi Diabetes Complications Study

Acronym

Follow-up Study of the Asahi study

Scientific Title

Follow-up Study of the Asahi Diabetes Complications Study

Scientific Title:Acronym

Follow-up Study of the Asahi study

Region

Japan

Condition

Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This is a follow-up study after the completion of a prospective observational study (the Asahi Study) by constructing a database on the actual status of complications and their treatment in diabetes mellitus. The established database of diabetic patients will be followed for a longer period to more accurately assess diabetic complications.

Basic objectives2

Others

Basic objectives -Others

The primary analysis will be the frequency of each complication in the cohort and the impact of each complication on glycemic, blood pressure, hyperlipidemic, and other controls. The Kaplan-Meier method will be used to estimate the time to end-point in each stage group based on nephropathy staging. The difference in time to end-point between each nephropathy stage group will be tested by the log-rank test. In addition, hazard ratios and their 95% confidence intervals will be calculated using the Cox proportional hazards model.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

1.Nephropathy
The first period: consecutive 2 measured albuminuria in patients without microalbuminuria (urinary albumin/ creatinine ratio, 30mg/g Cr or greater)
The second period: appearance of overt proteinuria (urinary albumin/ creatinine ratio, 300mg/g Cr or greater), > 2-fold increases in serum creatinine, eGFR 30 to 40% reduction, or initiation of dialysis in those with microalbuminuria.
2. Retinopathy
Development of retinopathy or progression of disease from simple, non-proliferative retinopathy to proliferative retinopathy or blindness.
3. Macroangiopathy
Ischemic heart disease (e.g. cardiac revascularization, myocardial infraction), heart failure requiring hospitalization, cerebrovascular disease (e.g. cerebral hemorrhage or cerebral infarction requiring hospitalization) except transient cerebral ischemic attack.
Lower extremity amputation, peripheral revascularization.
4. Malignancy
Mortality from malignant tumor (hepatocellular carcinoma, pancreatic carcinoma, colorectal cancer etc.)
5. Mild cognitive impairment
Appearance of mild cognitive impairment (MOCA-J score of 25 or less)
6.Sarcopenia
Appearance of sarcopenia (AGWS: Diagnostic criteria for sarcopenia in Asians)
7. Decline in ADL
DASC8 (Category 1: 10 points or less, Category 2: 11-16 points, Category 3: 17 points or more)
8. Severe hypoglycemia
Occurrence of severe hypoglycemia (hypoglycemia requiring assistance of others and/or hospitalization)
9. Hospitalization due to heart failure
10. Occurrence of bone fracture

Key secondary outcomes

1.all-cause mortality
2.complication
retinopathy: photocoagulation, vitreous surgery, blindness
neuropathy: ulcer or gangrene
malignancy: incidence of malignancy
3.medical expenses

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

Type 1 and type 2 diabetes mellitus

Key exclusion criteria

1)Patient without diabetes
2)Impaired glucose tolerance
3)Other types of diabetes mellitus due to specific causes
4)Gestational diabetes mellitus
5)Overt diabetes in pregnancy
6)Patients who are difficult to judge whether to participate in the study
7)Patient judged inappropriate for the doctor in charge

Target sample size

858

Name of lead principal investigator

1st name	Masato
Middle name
Last name	Kasuga

Organization

The Institute of Medical Science, Asahi Life Foundation

Division name

Director

Zip code

1030002

Address

2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo

TEL

03-3639-5501

Email

m-kasuga@asahi-life.or.jp

Name of contact person

1st name	Yoko
Middle name
Last name	Yoshida

Organization

The Institute of Medical Science, Asahi Life Foundation

Division name

Division of Diabetes and Metabolism

Zip code

1030002

Address

2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo

TEL

0336395501

Homepage URL

Email

y-yoshida@asahi-life.or.jp

Institute

The Institute of Medical Science, Asahi Life Foundation

Institute

Department

Personal name

Organization

The Institute of Medical Science, Asahi Life Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research ethics committee , the Institute of Medical Science, Asahi Life Foundation

Address

2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo

Tel

0336395501

Email

t-sumida@asahi-life.or.jp

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

2023

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

858

Results

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

No longer recruiting

Date of protocol fixation

2020

Year

02

Month

10

Day

Date of IRB

2020

Year

02

Month

10

Day

Anticipated trial start date

2020

Year

02

Month

10

Day

Last follow-up date

2026

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Social awareness of the early detection of diabetes has increased, and new therapeutic agents and technologies have become widely available. On the other hand, the situation surrounding diabetes in Japan has been changing due to the westernization and aging of the population. Against this background, we have started a prospective study (the Asahi Study) by constructing a database on the actual status of complications of diabetes and their treatment.
In 2019, a survey on cognitive dysfunction and sarcopenia and assessment of blood glucose patterns by IsCGM were added to the study.
However, enrollment was much lower than originally planned, making it difficult to ensure event counts at the 5-year follow-up. Longer follow-up was needed to assess complications, and a follow-up study was decided to be conducted.

Registered date

2023

Year

12

Month

13

Day

Last modified on

2023

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060573