UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004512 |
|---|---|
| Receipt number | 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 07:16:52 |
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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
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
anb72547@nifty.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005389
