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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005013
Receipt No. R000005961
Scientific Title Okayama prospective oBservational study for the Effect by Sitagliptin on obesE type2 diabetes
Date of disclosure of the study information 2011/02/04
Last modified on 2015/08/04

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Basic information
Public title Okayama prospective oBservational study for the Effect by Sitagliptin on obesE type2 diabetes
Acronym OBESE
Scientific Title Okayama prospective oBservational study for the Effect by Sitagliptin on obesE type2 diabetes
Scientific Title:Acronym OBESE
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of sitagliptin for type 2 diabetes patients with obesity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percent and degree of change about HbA1c when treatment begins and after 3 months.
Key secondary outcomes The normal rate about HbA1c and fasting blood glucose when treatment begins and after 3, 6 or 12 months.
Measure of weight, blood pressure, adverse events, pancreatic beta-cell function and lipid effects, high-sensitivity CRP, urine qualitative and microalbuminuria, 1.5AG, oxidative stress, cytokines, BNP.

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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with type 2 diabetes (HbA1c 6.5-10% JDS) under life style intervention or treating with oral medicine
2)Age >=20 years, Male and Female
3)written informed consent
Key exclusion criteria 1)type 1 diabetes
2)history of severe ketosis or diabetic coma
3)Patients having severe infection, before and after operation and trauma
4)Impaired renal function (serum-creatinine: Male >=1.5mg, Female >=1.3mg)
5)history of stroke, myocardial infarction or other severe vascular complication
6)Patients treating with DPP-IV inhibitor except for sitagliptin
7)Patients treating with gurinido or insulin at initiation time
8)patients who treated with sulfonylurea (>=glimepilide 2mg/day, >= glibenclamide 1.25mg/day or >=gliclazide 40mg/day at initiation time
9)pregnancy
10)history of anaphylaxis of itagliption
11)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Makino
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Okayama
TEL 086-235-7235
Email makino@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Shikata
Organization Okayama University Hospital
Division name Centor for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho, Okayama
TEL 086-235-6510
Homepage URL
Email okadmnet@md.okayama-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science,Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences,
Institute
Department

Funding Source
Organization Okayama Medical Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岡山大学病院(岡山県)、心臓病センター 榊原病院(岡山県)、岡山労災病院(岡山県)、岡山済生会総合病院(岡山県)、おさふねクリニック(岡山県)、岡山市立市民病院(岡山県)、岡山医療センター(岡山県)、岡山赤十字病院(岡山県)、津山中央病院(岡山県)、落合病院(岡山県)、浅野内科(岡山県)、宿毛診療所(岡山県)、河合内科西口クリニック(岡山県)、宮島医院(岡山県)、あけぼのクリニック(岡山県)、中国中央病院(広島県)、金光病院(岡山県)、因島総合病院(広島県)、はしもとじんクリニック(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 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 Completed
Date of protocol fixation
2010 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Age, gender, height, weight, abdominal circumference, BMI, drinking and smoking status, diabetes duration, complications (cardiovascular disease, renal failure, liver failure, stroke, hypertension, lipid disorders), lifestyle-related diseases and drug prescription conditions (diabetes medications, antihypertensive drugs, lipid disorders treatment, antithrombotic drugs, therapeutic blood high uric acid).
Evaluation of changes (blood glucose, HbA1c, 1.5 AG), weight, blood pressure, adverse events, pancreatic beta-cell function and lipid effects, high-sensitivity CRP, urine qualitative and microalbuminuria when treatment begins and after 3, 6 or 12 months.
Oxidative stress, cytokines, BNP levels when treatment begins and after 12 months.

Management information
Registered date
2011 Year 02 Month 03 Day
Last modified on
2015 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005961

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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