UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of change in blood glucagon levels in response to orally glucose loading and food intake
Acronym	Measurement of blood glucagon levels in glucose tolerance and meal tolerance test
Scientific Title	Evaluation of change in blood glucagon levels in response to orally glucose loading and food intake
Scientific Title:Acronym	Measurement of blood glucagon levels in glucose tolerance and meal tolerance test
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine change in blood glucagon levels of normal glucose tolerant subjects and diabetes patients in response to orally glucose loading and food intake, we will measure blood glucagon levels using relatively glucagon-specific new ELISA method.
Basic objectives2	Others
Basic objectives -Others	We will also measure blood glucagon levels by using conventional RIA kits to clarify which kit of sandwich ELISA or conventional RIA is more suitable to attain the objective1.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The time course (0, 30, 60, 120, 180 min after loading) of blood glucagon levels in diabetes patients in response to glucose loading or food intake will be compared with those in normal glucose tolerant subjects.
Key secondary outcomes	In addition, blood glucose, insulin, and incretin levels will be measured and analyzed in accordance with kinetic changes in blood glucagon levels.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Normal subjects 1) 20 - 69 years old 2) HbA1c is less than 6.2% 3) person who do not regularly use medicine Diabetes patients 1) 20 - 69 years old 2) patients who are not receiving medication for diabetes
Key exclusion criteria	1) abnormal in liver or renal function test 2) a woman within 12 weeks expected to give birth 3) impaired cardiopulmonary function 4) anemia symptoms 5) chronic or acute infections according to the judgment of doctor 6) persons who are participating in other clinical trials at the start of this study 7) subjects judged by investigator as inappropriate
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Tadahiro Middle name Last name Kitamura
Organization	Institute for Molecular and Cellular Regulation, Gunma University
Division name	Metabolic Signal Research Center
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	+81-27-220-8845
Email	kitamura@gunma-u.ac.jp

Public contact
Name of contact person	1st name Tadahiro Middle name Last name Kitamura
Organization	Institute for Molecular and Cellular Regulation, Gunma University
Division name	Metabolic Signal Research Center
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	+81-27-220-8845
Homepage URL
Email	hitotaisho-ciru@ml.gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Cosmic Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel	+81-27-220-7111
Email	hitotaisho-ciru@ml.gunma-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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 30 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	Completed
Date of protocol fixation	2017 Year 05 Month 29 Day
Date of IRB	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 06 Month 30 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is categorized into observational study, in which collected blood samples are assayed for glucagon by commercially available glucagon test kits. 1. Glucagon test kits Glucagon ELISA (Cosmic), Glucagon RIA KIT (Merck Millipore), Glucagon RIA SML (Sceti Medical Lab). 2. Study subjects 20 healthy subjects 50 diabetes patients 3. Blood sampling Blood is intravenously collected using P800 blood sampling tube(Becton Dickinson) 4. Test schedule Fasting subjects (Healthy subjects and diabetes paitients) take Torelan G or Sanet SA. Blood samples of 10 mL are collected at 0, 30, 60, 120, 180 min after glucose or food intake. A subject participates both glucose tolerance and meal tolerance tests on separate days on the interval of 1-4 weeks. 5. Prohibited treatments Pharmaceuticals and herbal medicine without previous experience of use 6. Treatments that can be done together with this study None 7. Data extraction from medical record Sex, date of birth, age, height, weight, blood pressure, liver and renal function test results, lipid metabolism data, and HbA1c. 8. Examination and evaluation items Just before tolerance test: HbA1c (healthy subject), blood glucose, glucagon, insulin, incretin, subjective symptom, objective symptom 30, 60, 120, 180 min after glucose or meal intake: blood glucose, glucagon, insulin, incretin, subjective symptom, objective symptom, adverse event

Management information
Registered date	2017 Year 06 Month 21 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031591