UMIN-CTR Clinical Trial

Public title

Study on association between beta cell function and glycemic variability in the non-diabetic subjects with normal glucose tolerance and impaired glucose tolerance

Acronym

Study on association between beta cell function and glycemic variability in the non-diabetic subjects with normal glucose tolerance and impaired glucose tolerance

Scientific Title

Study on association between beta cell function and glycemic variability in the non-diabetic subjects with normal glucose tolerance and impaired glucose tolerance

Scientific Title:Acronym

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

diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhiko Sakaguchi

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology

Zip code

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-5111

Email

kzhkskgc@med.kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomoaki Nakamura

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology

Zip code

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan

TEL

078-382-5111

Homepage URL

Email

tomnak@med.kobe-u.ac.jp

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name

Organization

donation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

11

Month

11

Day

Date of IRB

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

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

Registered date

2015

Year

11

Month

30

Day

Last modified on

2019

Year

02

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020535