UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016133 |
|---|---|
| Receipt number | R000018673 |
| Scientific Title | Alternation in glucagon secretion associated with progression of glucose intolerance. |
| Date of disclosure of the study information | 2015/01/06 |
| Last modified on | 2019/07/12 14:01:52 |
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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
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
raizo@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018673
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