| Trial ID: | L0932 |
| Source ID: | KCT0000505
|
| Associated Drug: |
Carnitine complex
|
| Title: |
A randomized, placebo controlled, double blind, multi center, parallel designed phase IV clinical study to evaluate the efficacy and safety of Carnitine complex(Godex??) in type II diabete patients with Non-Alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
;Endocrine, nutritional and metabolic disease
|
| Interventions: |
Drug : 1. Combination therapy treatment group<br>1) Carnitine complex; carnitine orotate complex(brand name: GODEX cap.), 412mg/cap., 2cap. tid, peroral<br>2) Oral antidiabetics; All oral antidiabetics except for TZD(thiazolidinedione). No change in dosag
|
| Outcome Measures: |
The rate of ALT normalizationThe changes and change rate of glycemic control (fasting glucose, fasting insulin, C-peptide, HbA1c);The changes of insulin resistance(HOMA-IR, beta);The changes of non-alcoholic fatty liver disease(CT, NFS; NAFLD fibrosis score);The evaluation of non-invasive arteriosclerotic degree(PWV; pulse wave velosity);The changes of waist circumference
|
| Sponsor/Collaborators: |
Celltrion Pharm
|
| Gender: |
All
|
| Age: |
20(Year)70(Year)
|
| Phases: |
Phase 4
|
| Enrollment: |
74
|
| Study Type: |
Interventional Study
|
| Study Designs: |
Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Caregiver, Allocation : RCT
|
| Start Date: |
14/08/2012
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
11 March 2019
|
| Locations: |
Korea, Republic of
|
| URL: |
http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=4943
|
