UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014171 |
|---|---|
| Receipt number | R000016505 |
| Scientific Title | Introduction of indices of clinical insulin resistance / sensitivity under significant urinary glucose excretion |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2018/06/07 09:29:06 |
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Basic information
Public title
Introduction of indices of clinical insulin resistance / sensitivity under significant urinary glucose excretion
Acronym
indices of insulin sensitivity under using SGLT-2 inhibitors (ISUUSI)
Scientific Title
Introduction of indices of clinical insulin resistance / sensitivity under significant urinary glucose excretion
Scientific Title:Acronym
indices of insulin sensitivity under using SGLT-2 inhibitors (ISUUSI)
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
OGTT (oral glucose tolerance test) will be appled to subjects with type 2 dibetes mellitus who are using SGLT-2 inhibitors. The data obtained during OGTT is used to assess insulin sensitivity and insulin resistance.
Basic objectives2
Others
Basic objectives -Others
Urine excretion during OGTT
change of HOMA-beta or insulinogenic index (if any)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of muscle insulin sensitivity and liver insulin resistance (should be consistant to the effect of SGLT-2 inhibitors, when compared with previous studies)
Key secondary outcomes
1)Exsitence of difference between the new indices and HOMA-IR or Matsuda index without considering urine glucose excretion
2)Consistence of beta cell function measured by HOMA-beta or insulinogenic inex
3)Any changes in the disposition index
4)Existance of urinary glucose excretion after terminatio of SGLT-2 inhibitors
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects should be type 2 diabetic patients who have stable glycemic control for more than 2 months, and their HbA1c should be less than 8.0 %. Subjects who are taking pioglitazone or metformin or DPP-4 inhibitors will be also enrolled.
Key exclusion criteria
1) Under the treatment with insulin
2) Type 1 diabetic subjects or diabetic subjects who have HbA1c more than or equal to 8.0 % or who need admission because of diabetic ketoacidosis or extreme hyperglycemia.
3) Subjects who are treated with sulfonylureas (i.e. glibenclamide, glimepiride, or gliclazide).
4) Subjects with nephrotic syndrome (urine protein more than or equal to 3.5g/day and serum protein less than or equal to 6.0 g/dl [or serum albumin less than or equal to 3.0 g/dl].
5) Subjects who are taking steroids, immune suppression medication, antifungal medication of azoles. HIV protease inhibitors
6) Subjects who had brain stroke or acute coronary syndrome within 6 months before enrollment.
7) Subjects with severe heart failure (NYHA class 3 or higher), severe arrhythmia (frequent atrial or ventral arrhythmia, continuous ventricular tachycardia, severe atrial tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome or atrial-ventral block with severe bradycardia).
8) Subjects who have AST or ALT more than 5 times of upper normal limit of their institute
9) Subjects with malignancy
10) Subjects who are pregnant or who have intention to be pregnant
11) Subjects with other situations under which a doctor in charge decides that subjects are not eligible for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
049-228-3564
matsudam-ind@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Matsuda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama-ken
TEL
049-228-3564
Homepage URL
matsudam-ind@umin.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Diabetes
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology and Diabetes
Saitama Medical Center, Saitama Medical University
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
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
埼玉医科大学総合医療センター
内分泌・糖尿病内科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Insulin sensitivity will be examined by condcting OGTT before and after the use of an SGLT2 inhibitor.
Due to the problem of assay of glucagon this study has not been initiated.
Management information
Registered date
| 2014 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016505
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| Registered date | File name |
| Research case data | |
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