UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014508 |
|---|---|
| Receipt number | R000016596 |
| Scientific Title | The Effects of 6-Month DPP-4 inhibitor Treatment in Diabetic Patients during Oral Glucocorticoids Administration |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2015/12/22 18:49:21 |
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Basic information
Public title
The Effects of 6-Month DPP-4 inhibitor Treatment in Diabetic Patients during Oral Glucocorticoids Administration
Acronym
The Effects of 6-Month DPP-4 inhibitor Treatment in Diabetic Patients during Oral Glucocorticoids Administration
Scientific Title
The Effects of 6-Month DPP-4 inhibitor Treatment in Diabetic Patients during Oral Glucocorticoids Administration
Scientific Title:Acronym
The Effects of 6-Month DPP-4 inhibitor Treatment in Diabetic Patients during Oral Glucocorticoids Administration
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 6-month DPP-4 inhibitor treatment in diabetic patients with administering oral glucocorticoids
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, HbA1c (NGSP)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetic patients who had taken sitagliptin and oral corticosteroids for 6 months or longer
Key exclusion criteria
Type 1 diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayuki Katsuyama |
Organization
National Center for Global Health and Medicine, Kohnodai Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL
+81-47-372-3501
katsuyama-hs@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayuki Katsuyama |
Organization
National Center for Global Health and Medicine, Kohnodai Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL
+81-47-372-3501
Homepage URL
katsuyama-hs@umin.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine, Kohnodai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2014 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25883713
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
| 2014 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
We obseveved compared the data before the sitagliptin treatment with the data at 6 month after the sitagliptin treatment started.
Body weight, BMI, blood pressure, plasma glucose, hemoglobin A1c (HbA1c), serum low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), estimated glomerular filtration rate (eGFR), the amount of adrenal corticoides.
Management information
Registered date
| 2014 | Year | 07 | Month | 08 | Day |
Last modified on
| 2015 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016596
