UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on association between beta cell function and glycemic variability in the non-diabetic subjects with normal glucose tolerance and impaired glucose tolerance
Title of the study (Brief title)	Study on association between beta cell function and glycemic variability in the non-diabetic subjects with normal glucose tolerance and impaired glucose tolerance
Region	Japan

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

Objectives
Narrative objectives1	To investigate the association between beta cell function and glycemic variability in the subjects with normal glucose tolerance and impaired glucose tolerance.
Basic objectives2	Others
Basic objectives -Others	physiology of glucose metabolism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between the parameters of glycemic variability calculated from the continuous glucose monitoring data and the index of beta cell function calculated from the data of hyperglycemic clamp and euglycemic hyperinsulinemic clamp
Key secondary outcomes	1.Association between the parameters of glycemic variability calculated from the continous glucose monitoring data and the index of beta cell function calculated from the date of 75g oral glucose tolerance test (75g OGTT) 2.Association between the indices of beta cell function calculated from the data of 75g OGTT and glucose clamp 3.Association between anthropometric data, serum lipid profile, basal metabolic rate measured with indirect calorimeter and the parameters of glycemic variability or the indices of beta cell function

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.without diabetes mellitus 2.20 years of age or older 3.before the study, able to understand our explanation on the study and obtain the written informed consent based on their own free will
Key exclusion criteria	1.the use of medications that affect glucose metabolism (such as corticosteroids, beta-blockers) 2.existing or possible pregnancy 3.brestfeeding 4.an investigator's declaration that the participant was otherwise inappropriate for the study
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuhiko Sakaguchi
Organization	Kobe University Graduate School of Medicine
Division name	Division of Diabetes and Endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-5111
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	Tomoaki Nakamura
Organization	Kobe University Graduate School of Medicine
Division name	Division of Diabetes and Endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-5111
Homepage URL
Email	tomnak@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	donation
Organization
Division
Category of Funding Organization	Other
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	2015 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 11 Day
Anticipated trial start date	2015 Year 11 Month 11 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	Study Design: cross-sectional study Study Subjects: all non-diabetic individuals with normal glucose tolerance or impaired glucose tolerance who meet the selection criteria and are recruited at Division of Diabetes and Endocrinology in Kobe University Graduate School of Medicine from November 11, 2015 to October 24, 2016 through posters or leaflets on our study

Management information
Registered date	2015 Year 11 Month 30 Day
Last modified on	2019 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020535