| Trial ID: | L0948 |
| Source ID: | KCT0000193
|
| Associated Drug: |
Carnitine complex
|
| Title: |
Efficacy and safety of metformin plus carnitine complex(Godex) compaired with metformin monotherapy in type 2 DM and impaired glucose tolerance patients with non-alcoholic fatty liver disease; A randomized, placebo controlled, double blind, parallel desin
|
| 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/1capsule, 2cap. tid, peroral<br>2) Antidiabetic; metformin HCl(brand name; Diabex tab., 250mg/1tablet, 1tab. tid, peroral<br>2.
|
| Outcome Measures: |
The rate of ALT normalizationThe changes and change rate of glycemic control (fasting glucose, fasting insulin, HbA1c) ;The changes of plasma ALT levels;The changes of urine 8-OHdG;The changes of mitochondria DNA copy number
|
| Sponsor/Collaborators: |
Seoul National University Bundang Hospital
|
| Gender: |
All
|
| Age: |
18(Year)79(Year)
|
| Phases: |
Phase 4
|
| Enrollment: |
58
|
| Study Type: |
Interventional Study
|
| Study Designs: |
Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
|
| Start Date: |
04/10/2011
|
| Completion Date: |
--
|
| Results First Posted: |
04/10/2011
|
| Last Update Posted: |
11 March 2019
|
| Locations: |
Korea, Republic of
|
| URL: |
http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=4802
|
