UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical significance of urine-DPP-4 activity in patients with type2 diabetes.
Title of the study (Brief title)	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	Hiroaki Masuzaki,MD,phD
Organization	Faculty of Medicine, University of the Ryukyus
Division name	Second Department of Internal Medicine
Address	207 Uehara, Nishihara, Okinawa
TEL	098-895-1146
Email	ikyoku@ryudai2nai.com

Public contact
Name of contact person	Rei Ueda, MD
Organization	Faculty of Medicine, University of the Ryukyus
Division name	Second Department of Internal Medicine
Address	207 Uehara, Nishihara, Okinawa
TEL	098-895-1146
Homepage URL
Email	ikyoku@ryudai2nai.com

Sponsor
Institute	Second Department of Internal Medicine,Second Department of Internal Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020199