UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022808 |
|---|---|
| Receipt number | R000026283 |
| Scientific Title | Association between Max body weight and diabetes complications in type 2 diabetes |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2016/06/20 17:11:14 |
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Basic information
Public title
Association between Max body weight and diabetes complications in type 2 diabetes
Acronym
Association between Max body weight and diabetes complications in type 2 diabetes
Scientific Title
Association between Max body weight and diabetes complications in type 2 diabetes
Scientific Title:Acronym
Association between Max body weight and diabetes complications 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
To investigate the association between lifetime weight gain ; delta max BW (maximum lifetime body weight - body weight at age 20 years) and diabetes complications in type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between delta max BW and diabetes retinopathy and 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients and newly visited outpatients with type 2 diabetes in Saiseikai Yokohama City Nanbu Hospital from January 2015 to March 2016.
Key exclusion criteria
Patients who diagnosed type 2 diabetes before 20 years old.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo terauchi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Endocrinology and metabolism
Zip code
Address
3-9 Fukuura,Kanazawa-ku, Yokohama,Kanagawa
TEL
045-787-2639
terauchi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minori Horii |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Endocrinology and metabolism
Zip code
Address
3-9 Fukuura,Kanazawa-ku, Yokohama,Kanagawa
TEL
045-787-2639
Homepage URL
minorit-tkb@umin.ac.jp
Sponsor or person
Institute
Saiseikai Yokohama City nanbu hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2016 | Year | 06 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
Cross-sectional study.
Subjects are hospitalized patients and newly visited outpatients with type 2 diabetes in Saiseikai Yokohama City Nanbu Hospital from January 2015 to March 2016.
To investigate the association between lifetime weight gain ; delta max BW and diabetic retinopathy and nephropathy.
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026283
