UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016259 |
|---|---|
| Receipt number | R000018867 |
| Scientific Title | The assessment of endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients using a euglycemic insulin clamp technique with [6,6-2D2]glucose infusion, non-randomized intergroup trial |
| Date of disclosure of the study information | 2015/01/19 |
| Last modified on | 2018/10/04 11:06:17 |
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Basic information
Public title
The assessment of endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients using a euglycemic insulin clamp technique with [6,6-2D2]glucose infusion, non-randomized intergroup trial
Acronym
Endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients.
Scientific Title
The assessment of endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients using a euglycemic insulin clamp technique with [6,6-2D2]glucose infusion, non-randomized intergroup trial
Scientific Title:Acronym
Endogenous glucose production and insulin-stimulated glucose disposal in type 2 diabetes patients.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess organ-specific insulin resistance in the liver (endogenous glucose production) and skeletal muscle (insulin-stimulated glucose disposal) in Japanese type 2 diabetes patients using a euglycemic insulin clamp technique with [6,6-2D2]glucose infusion.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Endogenous glucose production and insulin-stimulated glucose disposal.
Key secondary outcomes
1) Suppression of endogenous glucose production by insulin.
2) Plasma glucose, plasma insulin, C-peptide and free fatty acid.
3) The association of fasting plasma glucose, HbA1c, HOMA-IR, HOMA-beta, CPI, hepatic function, blood-cholesterol level and hematological value with endogenous glucose production and insulin-stimulated glucose disposal.
4) Safety
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Until March 31, 2018.Type 2 diabetes patients with fatty liver and obesity undergo a euglycemic insulin clamp technique once.
Interventions/Control_2
Until March 31, 2018. Type 2 diabetes patients without fatty liver and obesity undergo a euglycemic insulin clamp technique once.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Hospitalized type 2 diabetes patients.
2) Age is over 20 years and less than 80 years.
3) Patients who can undergo euglycemic insulin clamp technique within seven days of admission.
4) Patients with CAP(controlled attention parameter) > 232.5 dB/m and BMI(body mass index) > 25 kg/m2, or with CAP < 232.5 dB/m and BMI < 25 kg/m2.
5) Patients who obtained document agreement by free will of themselves on
understanding after enough explanation when participating about examination is received.
Key exclusion criteria
1) Patients with known bleeding disorders.
2) Type 1 diabetes and secondary diabetes patients.
3) Patients with severe renal disease(s-Cre > 2.0 mg/dl).
4) Patients with severe liver disease (AST or ALT > 100 IU/L).
5) Patients who are unable to be responsible for informed consent due to severe psychiatric disease.
6) Excessive common custom drinker (alcohol > 100 ml/day).
7) Patients who have a history of hypersensitivity.
8) Pregnant or possibly pregnant women.
9) Women on lactation.
10) In addition, patients who were judged inappropriate by an attendant physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto kubota |
Organization
Tokyo University
Division name
Department of Diabetes and Endocrinology
Zip code
Address
7-3-1 Hongo, Bunkyouku, Tokyo, Japan
TEL
03-3815-5411
nkubota-tky@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Morita |
Organization
Tokyo University
Division name
Department of Diabetes and Endocrinology
Zip code
Address
7-3-1 Hongo, Bunkyouku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
imo33edo@gmail.com
Sponsor or person
Institute
Tokyo University faculty of Medicine
Department of Diabetes and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Tokyo University faculty of Medicine
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
Address
Tel
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 | 19 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 04 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018867
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