UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027852 |
|---|---|
| Receipt number | R000031591 |
| Scientific Title | Evaluation of change in blood glucagon levels in response to orally glucose loading and food intake |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2021/06/23 13:45:07 |
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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
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
hitotaisho-ciru@ml.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031591
