UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038067