UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033387 |
|---|---|
| Receipt number | R000038067 |
| Scientific Title | Evaluation of glucagon secretion in type 2 diabetes |
| Date of disclosure of the study information | 2018/07/13 |
| Last modified on | 2021/04/12 20:09:19 |
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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
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
holy197741@me.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/33369175/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33369175/
Number of participants that the trial has enrolled
23
Results
The levels of plasma glucagon were elevated and peaked 30 min after the mixed meal ingestion in both type 1 diabetes and type 2 diabetes patients.
Results date posted
| 2021 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Controlling postprandial glucose levels in patients with type 1 diabetes is challenging even under the adequate treatment of insulin injection. Recent studies showed that dysregulated glucagon secretion exacerbates hyperglycemia in type 2 diabetes patients, but little is known in type 1 diabetes patients. We investigated whether the glucagon response to a meal ingestion could influence the postprandial glucose excursion in patients with type 1 diabetes.
Participant flow
We enrolled 34 patients with type 1 diabetes and 23 patients with type 2 diabetes as controls.
Adverse events
None
Outcome measures
All patients underwent a liquid mixed meal tolerance test. We measured levels of plasma glucose, C-peptide and glucagon at fasting (0 min), and 30, 60 and 120 min after meal ingestion. All type 1 diabetes patients received their usual basal insulin and two-thirds of the necessary dose of the premeal bolus insulin.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 01 | Day |
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
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038067
