UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026502
Receipt No. R000030436
Scientific Title Comparison of fluctuation of glucagon after oral glucose, protein or lipid intake in healthy Japanese adult.
Date of disclosure of the study information 2017/03/10
Last modified on 2017/09/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of fluctuation of glucagon after oral glucose, protein or lipid intake in healthy Japanese adult.
Acronym The fluctuation of glucagon after glucose, protein or lipid intake.
Scientific Title Comparison of fluctuation of glucagon after oral glucose, protein or lipid intake in healthy Japanese adult.
Scientific Title:Acronym The fluctuation of glucagon after glucose, protein or lipid intake.
Region
Japan

Condition
Condition healthy Japanese adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the differences in plasma glucagon fluctuations between after each oral glucose, protein and lipid intake in healthy Japanese adult.
Basic objectives2 Others
Basic objectives -Others Investigation on changes in hormone secretion behavior by nutrient intake.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Measure glucagon values of before and 30 minutes, 60 minutes, 90 minutes and 120 minutes after each oral glucose, protein and lipid intake, and compare differences in glucagon fluctuations due to ingesting each nutrient.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 After an overnight fast of 10 hours or more, ingest glucose 75g equivalent to 300 kcal a single time.
Interventions/Control_2 After an overnight fast of 10 hours or more, ingest whey protein 82g equivalent to 300 kcal a single time.
Interventions/Control_3 After an overnight fast of 10 hours or more, ingest olive oil 32g equivalent to 300 kcal a single time.
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
40 years-old >=
Gender Male and Female
Key inclusion criteria 1.It is not pointed out abnormality of glucose metabolism by health examination.
2.Body mass index (BMI) is 18.5 or more and less than 25.0.
Key exclusion criteria 1. In case of suffering from acute diseases.
2. In case of malignant disease and its history.
3. Pregnant women or women who may be pregnant.
4. Women who are breastfeeding.
5. Cases with difficult informed consent acquisition.
6. Example of complication of endocrine disorder
7. Examples of medications with known side effects causing glucose metabolism abnormalities (steroid drugs, interferons, etc.)
8. Subjects who have allergy to milk and milk-derived ingredients.
9. Subjects who have allergy to olive oil.
10. If there is a weight gain of 5% or more in the last month.

Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Raishi Ichikawa
Organization Kitasato University, School of Medicine
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa, Japan
TEL 042-778-8111
Email raizo@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Raishi Ichikawa
Organization Kitasato University, School of Medicine
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email raizo@med.kitasato-u.ac.jp

Sponsor
Institute Department of Endocrinology, Diabetes and Metabolism, Kitasato University, School of Medicine
Institute
Department

Funding Source
Organization Department of Endocrinology, Diabetes and Metabolism, Kitasato University, School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北里大学医学部

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 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
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
2017 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 10 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.