UMIN-CTR Clinical Trial

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

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Okayama Medical Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

02

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2011

Year

02

Month

03

Day

Last modified on

2015

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005961