UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026502
Receipt number 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 2023/08/25 12:01:41

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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 Raishi
Middle name
Last name Ichikawa

Organization

Kitasato University, School of Medicine

Division name

Department of Endocrinology, Diabetes and Metabolism

Zip code

252-0374

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 Raishi
Middle name
Last name Ichikawa

Organization

Kitasato University, School of Medicine

Division name

Department of Endocrinology, Diabetes and Metabolism

Zip code

252-0374

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 or person

Institute

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

Institute

Department

Personal name



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

Kitasato University, School of Medicine

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa, Japan

Tel

042-778-8111

Email

rinri-n@kitasato-u.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

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

10

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data analysis delays

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

Main results already published

Date of protocol fixation

2017 Year 03 Month 09 Day

Date of IRB

2017 Year 03 Month 09 Day

Anticipated trial start date

2017 Year 03 Month 10 Day

Last follow-up date

2020 Year 01 Month 31 Day

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

2023 Year 08 Month 25 Day



Link to view the page

Value
https://center6.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