UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027852
Receipt No. 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 2017/12/21

* 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 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
Middle name
Last name Tadahiro Kitamura
Organization Institute for Molecular and Cellular Regulation, Gunma University
Division name Metabolic Signal Research Center
Zip code
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
Middle name
Last name Tadahiro Kitamura
Organization Institute for Molecular and Cellular Regulation, Gunma University
Division name Metabolic Signal Research Center
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL +81-27-220-8845
Homepage URL
Email hos-webmaster@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
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

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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 30 Day
Last follow-up date
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
2017 Year 12 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.