UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036421
Receipt number R000041309
Scientific Title Effects of glutamine preload on post prandial blood glucose with 75g OGTT: crossover study in healthy volunteers.
Date of disclosure of the study information 2020/03/31
Last modified on 2019/04/03 20:04:11

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Basic information

Public title

Effects of glutamine preload on post prandial blood glucose with 75g OGTT: crossover study in healthy volunteers.

Acronym

Effects of glutamine preload on post prandial blood glucose with 75g OGTT: crossover study in healthy volunteers.

Scientific Title

Effects of glutamine preload on post prandial blood glucose with 75g OGTT: crossover study in healthy volunteers.

Scientific Title:Acronym

Effects of glutamine preload on post prandial blood glucose with 75g OGTT: crossover study in healthy volunteers.

Region

Japan


Condition

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether a single amino acid preload affectes the results of 75gOGTT

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

75gOGTT

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

glutamine preload

Interventions/Control_2

water preload (control)

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adults without diabetes
BMI at screening: 18 kg / m2 or more and 30 kg / m2 or less
Hemoglobin (Hb) is 13.0 g / dL or more for men and 12.5 g / dL or more for women

Key exclusion criteria

(1) Person using medicines
(2) Person with renal dysfunction
(3) Person with liver dysfunction
(4) Person who has a history of cerebrovascular disorder or cardiovascular disorder
(5) Patients with heart failure (NYHA classification I to IV)
(6) Person who has a history of digestive tract surgery
(7) Person who has excessive drinking habits
(8) Persons who cannot follow the instructions of researchers
(9) Persons participating in other research, clinical research.
(10) Pregnancy or possibility of pregnancy
(11) Person who was judged to be inappropriate

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Kuwata

Organization

Kansai Electric Power Medical Research Institute

Division name

Yutaka Seino Distinguished Center for Diabetes Center

Zip code

6500047

Address

1-5-6 Minatojimaminamimachi Chuo-ku Kobe 650-0047 Japan

TEL

078-303-6090

Email

kuwata-kob@umin.ac.jp


Public contact

Name of contact person

1st name HItoshi
Middle name
Last name Kuwata

Organization

Kansai Electric Power Medical Research Institute

Division name

Yutaka Seino Distinguished Center for Diabetes Center

Zip code

6500047

Address

1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan

TEL

078-303-6090

Homepage URL


Email

kuwata-kob@umin.ac.jp


Sponsor or person

Institute

Kansai Electric Power Medical Research Institute

Institute

Department

Personal name



Funding Source

Organization

Kansai Electric Power Medical Research Institute

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kansai Electric Power Hospital

Address

2-1-7 Fukushima-ku, Osaka 553-0003, Japa

Tel

06-6458-5821

Email

kuwata-kob@umin.ac.jp


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

2020 Year 03 Month 31 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

12

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

2019 Year 02 Month 08 Day

Date of IRB

2019 Year 02 Month 08 Day

Anticipated trial start date

2019 Year 02 Month 08 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 05 Day

Last modified on

2019 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name