UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between Max body weight and diabetes complications in type 2 diabetes
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuo terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and metabolism
Address	3-9 Fukuura,Kanazawa-ku, Yokohama,Kanagawa
TEL	045-787-2639
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	Minori Horii
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and metabolism
Address	3-9 Fukuura,Kanazawa-ku, Yokohama,Kanagawa
TEL	045-787-2639
Homepage URL
Email	minorit-tkb@umin.ac.jp

Sponsor
Institute	Saiseikai Yokohama City nanbu hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026283