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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033387
Receipt No. R000038067
Scientific Title Evaluation of glucagon secretion in type 2 diabetes
Date of disclosure of the study information 2018/07/13
Last modified on 2019/04/09

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Basic information
Public title Evaluation of glucagon secretion in type 2 diabetes
Acronym Type 2 diabetes and glucagon
Scientific Title Evaluation of glucagon secretion in type 2 diabetes
Scientific Title:Acronym Type 2 diabetes and glucagon
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of paradoxical secretion of glucagon in patients with type 2 diabetes
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of glucagon secretion when administered diet
Key secondary outcomes

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
12 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Diagnosed type 2 diabetes by diabetologists.
Key exclusion criteria Patients uncontrolled fasting glucose at 80-180 mg/dL.
Patients with cerebrovascular disease and/or cardiovascular disease.
Pregnant women.
Lactating women.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Horie
Organization Nagasaki University Hospital
Division name Endocrinology and Metabolism
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 0958197200
Email holy197741@me.com

Public contact
Name of contact person
1st name Ichiro
Middle name
Last name Horie
Organization Nagasaki University Hospital
Division name Endocrinology and Metabolism
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 0958197200
Homepage URL
Email holy197741@me.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Self funding
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 Nagasaki University Hospital Clinical Study Review Board
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7200
Email holy197741@me.com

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
2018 Year 07 Month 13 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
Participants are being enrolled.
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
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 07 Month 10 Day
Anticipated trial start date
2018 Year 07 Month 17 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Taking a 200ml of CalorieMate at fasting.
2. Blood sampling at 0, 30, 60, 90, 120 min after administration of CalorieMate.
3. Measure plasma glucose, insulin, C-peptide and glucagon in each sample.

Management information
Registered date
2018 Year 07 Month 13 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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