UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004512
Receipt No. R000005389
Scientific Title A prospetctive observational study to elucidate the safty and efficacy of GLP-1 analogue treatment for non-alcoholic steatohepatitis patients with type2 diabetes mellitus
Date of disclosure of the study information 2010/12/01
Last modified on 2013/11/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospetctive observational study to elucidate the safty and efficacy of GLP-1 analogue treatment for non-alcoholic steatohepatitis patients with type2 diabetes mellitus
Acronym NASH DM GLP-1 study
Scientific Title A prospetctive observational study to elucidate the safty and efficacy of GLP-1 analogue treatment for non-alcoholic steatohepatitis patients with type2 diabetes mellitus
Scientific Title:Acronym NASH DM GLP-1 study
Region
Japan

Condition
Condition NASH patients with type2 diabetes mellitus who have indication for GLP-1 analogue treatment.
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To eludidate the safty and efficacy of GLP-1 analogue treatment for NASH patients with type2 diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Imprpvment of the value of transaminase and NAFLD activity score.
Key secondary outcomes Imprpvment of the value of fasting blood sugar, HbA1c, and fasting blood concentration of insulin. Imprpvment of body weight, visveral fat areas, and fatty liver.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GLP-1 analogue treatment.
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.Age over 20 years.
2.Type2 DM patients who have not effectiveness with exercise therapy or alimentary therapy.
3.Type2 DM patients who have not effectiveness with sulfonylurea agent.
4.Type2 DM patients who are treated with other than sulfonylurea agent and have indication of treatment for combination therapy of sulfonylurea agent and GLP-1 analogue.
5.Type2 DM patients who are considering to quite insulin therpay by using GLP-1 analogue.
6.Abnormal elevation of GPT above normal upper limit over 6 months.
7.Taking alcohol less than 20g/day as 100% ethanol.
8.Patients who are excepted for other liver diseases by blood test.
9.Patients who agreed to this study via sufficient informed concent.
Key exclusion criteria 1.Patinets who have history of HBV or HCV infection, and auto-immune hepatitis.
2.Patients who take alcohol more than 20g/day as 100% ethanol.
3.Patients who have renal dysfunction (Cre over 2.0 mg/dl or eGFR less than 30 mL/min).
4.Patients who have platelet counts less than 50,000/micro-litter or prothrombin activity less than 50%.
5.Patients who have history of pancreatitis.
6.Patients who are treated with other clinical trial medicine.
7.Patients who have malignancy.
8.Patients who are judged no indication by whome resposible for this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamasa Ohki
Organization Mitsui Memorial Hospital
Division name Gastroenterology
Zip code
Address Kandaizumicho1 Chiyodaku Tokyo
TEL 03-3862-9111
Email anb72547@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takamasa Ohki
Organization Mitsui Memorial Hospital
Division name Gastroenterology
Zip code
Address Kandaizumicho1 Chiyodaku Tokyo
TEL 03-3862-9111
Homepage URL http://www.mitsuihosp.or.jp/index.html
Email anb72547@nifty.com

Sponsor
Institute Mitsui Memorial Hospital
Institute
Department

Funding Source
Organization Mitsui Memorial Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Tokyo, Department of Gastroenterology
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 三井記念病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 01 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 06 Day
Last modified on
2013 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.