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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024756
Receipt No. R000028471
Scientific Title Clinical benefit for diabetic vascular complication on non-invasive measurement of advanced glycogen endproduct level in type 2 diabetes
Date of disclosure of the study information 2016/11/08
Last modified on 2016/11/08

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Basic information
Public title Clinical benefit for diabetic vascular complication on non-invasive measurement of advanced glycogen endproduct level in type 2 diabetes
Acronym Clinical benefit for diabetic vascular complication on non-invasive measurement of advanced glycogen endproduct level in type 2 diabetes
Scientific Title Clinical benefit for diabetic vascular complication on non-invasive measurement of advanced glycogen endproduct level in type 2 diabetes
Scientific Title:Acronym Clinical benefit for diabetic vascular complication on non-invasive measurement of advanced glycogen endproduct level in type 2 diabetes
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 the study is to investigate the level of advanced glycogen endproduct (AGE), which was measured by non-invasive fluorescent AGE analyzer, and its correlation with macro- and micro-angiopathy in patient with type 2 diabetes.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between amounts of AGE constructs and degree of autofluorescence by irradiation of light and other experimental markers for macro- and micro-angiopathy (leukocyte counts, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, total protein, serum albumin, serum creatinin, BUN, UA, AST, ALT, LDH, CHE, ALP, g-GTP, total bilirubin, creatin kinase, fasting glucose level, fasting serum insulin level, HbA1c, glycated albumin, hs-CRP, urinaly albumin level, urinaly creatinin, mean- and max-IMT, baPWV, degree of retinopathy, degree of neuropathy, and degree of nephropathy.
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
100 years-old >
Gender Male and Female
Key inclusion criteria We will recruit 600 patients with type 2 diabetes who were hospitalized for glycemic control in Kumamoto University Hospital, Kagoshima University Hospital or Fukuoka University Hospital.
Key exclusion criteria 1. Patients with infectious disease
2. Patients with acute/chronic inflammatory disease
3. Patients with cancer
4. Patients with acute cerebrovascular disease
5. Patients with severe hepatic disease
6. Patients with severe respiratory
7. Patients with mental disorder
8. Patients decided from attended doctors not to be recruited in the study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Faculty of life sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Chuo, Kumamoto, Kumamoto, 860-8556, Japan
TEL 096-373-5169
Email takeshim@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Matsumura
Organization Kumamoto University Hospital
Division name Diabetes, Metabolism and Endocrinology
Zip code
Address 1-1-1 Honjo, Chuo, Kumamoto, Kumamoto
TEL 096-373-5169
Homepage URL
Email takeshim@gpo.kumamoto-u.ac.jp

Sponsor
Institute Human Ethics Review Committee of Kumamoto University
Institute
Department

Funding Source
Organization This work was supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 熊本大学大学院生命科学研究部代謝内科学分野、鹿児島大学大学院医歯学総合研究科糖尿病・内分泌内科学、福岡大学医学部内分泌・糖尿病内科

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 08 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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 Main factor in the study:
Measurement of serum AGE.

Subjects:Type 2 diabetes

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028471

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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