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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036421
Receipt No. 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

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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
Institute Kansai Electric Power Medical Research Institute
Institute
Department

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
URL(English) https://upload.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


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