| Trial ID: | L0067 |
| Source ID: | NCT03796975
|
| Associated Drug: |
Pioglitazone
|
| Title: |
Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes Mellitus|Non-alcoholic Fatty Liver Disease|Efficacy
|
| Interventions: |
Drug: Combination of Pioglitazone and Metformin Tablets|Drug: Metformin Hydrochloride Tablets
|
| Outcome Measures: |
Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound|Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index|Change of liver enzyme after 24 weeks treatment as assessed by blood test|Decreased of HbA1c after 24 weeks treatment as assessed by blood test|Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test|Change of weight and waistline after 24 weeks treatment as assessed by standard measurement
|
| Sponsor/Collaborators: |
Xijing Hospital|Second Affiliated Hospital of Xi'an Jiaotong University|Shaanxi Aerospace Hospital|Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd|Xi'an Gaoxin Hospital|Chang'An Hospital|Yan'an people's Hospital|Shangluo Central Hospital
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
120
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
June 28, 2018
|
| Completion Date: |
November 20, 2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
August 7, 2020
|
| Locations: |
Xijing Hospital, Fourth Military Medical university, Xi'an, Shaanxi, China
|
| URL: |
https://ClinicalTrials.gov/show/NCT03796975
|
