UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017417 |
|---|---|
| Receipt number | R000020199 |
| Scientific Title | Clinical significance of urine-DPP-4 activity in patients with type2 diabetes. |
| Date of disclosure of the study information | 2015/05/04 |
| Last modified on | 2017/05/08 13:00:20 |
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Basic information
Public title
Clinical significance of urine-DPP-4 activity in patients with type2 diabetes.
Acronym
Clinical significance of urine-DPP-4 activity in patients with type2 diabetes.
Scientific Title
Clinical significance of urine-DPP-4 activity in patients with type2 diabetes.
Scientific Title:Acronym
Clinical significance of urine-DPP-4 activity in patients with type2 diabetes.
Region
| Japan |
Condition
Condition
type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical significance and to explore the possibility of urine-DPP-4 activity as a clinical biomarker for glucose homeostasis in healthy volunteer and patients with type2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum-DPP-4 activity , urine-DPP-4 activity and metabolic marker ( body weight, plasma
levels of glucose, insulin, lipids ) of healthy volunteer and type2 diabetes patients.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
60 type 2 diabetes patients and 20 healthy volunteer
Key exclusion criteria
1.subjects who have severe renal dysfunction
2. subjects who have severe liver dysfunction
3. subjects who have insulin administration.
4. subjects who have malignant tumor.
5. expected, pregnant or lactating woman.
6. subjects to be inappropriate as an object of this examination by other reasons.
And, medical staff and students.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Masuzaki,MD,phD |
Organization
Faculty of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa
TEL
098-895-1146
ikyoku@ryudai2nai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rei Ueda, MD |
Organization
Faculty of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa
TEL
098-895-1146
Homepage URL
ikyoku@ryudai2nai.com
Sponsor or person
Institute
Second Department of Internal Medicine,Second Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine,Second Department of Internal 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
琉球大学医学部附属病院第2内科（沖縄県）
宜野湾海邦病院（沖縄県）
沖縄赤十字病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the clinical significance and to explore the possibility of urine-DPP-4 activity as a clinical biomarker for glucose homeostasis in healthy volunteer and patients with type2 diabetes.
Management information
Registered date
| 2015 | Year | 05 | Month | 04 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020199
