UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044304
Receipt No. R000050569
Scientific Title A prospective observational study to investigate the relationship between instability of glucose variability with age and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2021/07/01
Last modified on 2021/05/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospective observational study to investigate the relationship between instability of glucose variability with age and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Acronym The relationship between instability of glucose variability with age and diabetes-related complications or disorders
Scientific Title A prospective observational study to investigate the relationship between instability of glucose variability with age and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Scientific Title:Acronym The relationship between instability of glucose variability with age and diabetes-related complications or disorders
Region
Japan

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

Objectives
Narrative objectives1 The aim of our study is to investigate whether instability of glucose variability with age is associated with the onset and worsening of diabetes-related complications or disorders in Japanese patients with type 2 diabetes using continuous glucose monitoring.
Basic objectives2 Others
Basic objectives -Others To examine the relationship between instability of glucose variability with age and endogenous insulin secretion in Japanese patients with type 2 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between the change in glucose variability and clinical characteristics, glucose-related parameters or insulin secretion
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients with type 2 diabetes enrolled in the previous research (UMIN000029993) who have been getting outpatient treatment for over 1 year
2) 20 years of age or more
3) Patients undergoing continuous glucose monitoring
4) Written informed consent
Key exclusion criteria 1) Patients hospitalized within the past three months
2) Severe diabetic ketosis, diabetic coma within the past six months
3) Pregnancy, nursing woman or possibly pregnant woman
4) Patients who are taking kinds of steroid
5) Type 1 diabetes
6) Severe infection, pre and post operation, severe trauma
7) Patients having difficulty in dietary intake
8) Patients who are undergoing intermittently scanned continuous glucose monitoring
9) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Akinobu
Middle name
Last name Nakamura
Organization Hokkaido University Hospital
Division name Internal medicine II
Zip code 060-8638
Address N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Email akinbo@tim.hi-ho.ne.jp

Public contact
Name of contact person
1st name Akinobu
Middle name
Last name Nakamura
Organization Hokkaido University Hospital
Division name Internal medicine II
Zip code 060-8638
Address N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Homepage URL
Email akinbo@tim.hi-ho.ne.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address North 14, West 5, Kita-ku, Sapporo , Hokkaido
Tel 011-706-7061
Email none@none

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 北海道大学病院(北海道)
NTT東日本札幌病院(北海道)
苫小牧市立病院(北海道)
釧路赤十字病院(北海道)

Other administrative information
Date of disclosure of the study information
2021 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2021 Year 04 Month 22 Day
Date of IRB
2021 Year 05 Month 18 Day
Anticipated trial start date
2021 Year 05 Month 19 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study.

Management information
Registered date
2021 Year 05 Month 24 Day
Last modified on
2021 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050569

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.