UMIN-CTR Clinical Trial

Basic information
Public title	Alternation in glucagon secretion associated with progression of glucose intolerance.
Acronym	Glucagon secretion and progression of glucose intolerance.
Scientific Title	Alternation in glucagon secretion associated with progression of glucose intolerance.
Scientific Title:Acronym	Glucagon secretion and progression of glucose intolerance.
Region	Japan

Condition
Condition	normal glucose tolerance, impaired glucose metabolism, Type 2 diabetes mellitus (non-insulin dependent)
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between progression of glucose intolerance and alteration of glucagon secretion.
Basic objectives2	Others
Basic objectives -Others	Perform oral glucose tolerance test, and categorize participants into normal glucose tolerance, impaired glucose tolerance, diabetes mellitus, and compare the difference of alteration of glucagon secretion during glucose tolerance test between these three groups.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Compare the difference in alteration of glucagon secretion in oral glucose tolerance test between normal glucose tolerance, impaired glucose metabolism and type 2 diabetes mellitus (non-insulin dependent).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	normal glucose tolerance(fasting plasma glucose <110mg/dl(6.1mmol/l) and 2h-plasma glucose <140mg/dl(7.8mmol/l))at 75g oral glucose tolerance test.
Interventions/Control_2	impaired fasting glucose (fasting plasma glucose 110-126mg/dl(6.1-7.7mmol/l)), and/or impaired glucose tolerance (2h-plasma glucose 140-200mg/dl(7.8-11.1mmol/l)) at 75g oral glucose tolerance test.
Interventions/Control_3	fasting glucose >=126mg/dl(7.7mmol/l) and/or 2h-plasma glucose >=200mg/dl(11.1mmol/l) at 75g oral glucose tolerance test
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Type 2 (non-insulin dependent) diabetes subjects who are well-controlled in diet and exercise. 2. Patients undergo 75g oral glucose tolerance test to examine glucose tolerance. 3. Normal healthy volunteers.
Key exclusion criteria	1. A patient suffering from acute disease 2. In case of malignacy 3. Renal dysfunction (estimeted GFR <60ml/min) 4. Liver dysfunction (AST >100U/l, ALT >100U/l) 5. Pregnant or possibility of pregnant 6. Lactating mothers 7. A patient suffering from endocrine disorders 8. A patient administrated any drugs affect glucose metabolism 9. Diabetic patients who need any hypoglycemic agents 10. Fasting plasma glucose >=140mg/dl (7.8mmol/l) 11. Casual plasma glucose >=200mg/dl (11.1mmol/l) 12. Glycated hemoglobin (HbA1c) >=7.5%
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Raishi Middle name Last name Ichikawa
Organization	Kitasato University School of Medicine
Division name	Departmet of endocrinology, diabetes & metabolism
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Email	raizo@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Raishi Middle name Last name Ichikawa
Organization	Kitasato University School of Medicine
Division name	Departmet of endocrinology, diabetes & metabolism
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Homepage URL
Email	raizo@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University Medical Ethics Organization (KMEO), Institutional Review Board for Clinical Research and Treatment
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel	042-778-8273
Email	rinri-n@kitasato-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	2015 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ18-0372/_pdf/-char/en
Number of participants that the trial has enrolled	53
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 05 Month 28 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 12 Month 04 Day
Date of IRB	2014 Year 12 Month 04 Day
Anticipated trial start date	2014 Year 12 Month 05 Day
Last follow-up date	2018 Year 10 Month 01 Day
Date of closure to data entry	2018 Year 10 Month 01 Day
Date trial data considered complete	2018 Year 10 Month 01 Day
Date analysis concluded	2018 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2015 Year 01 Month 06 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018673