Antidiabetic Effects on Intrahepatic Fat
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03068065 |
Recruitment Status :
Completed
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
|
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 16, 2017 | |||
First Posted Date ICMJE | March 1, 2017 | |||
Last Update Posted Date | March 1, 2017 | |||
Actual Study Start Date ICMJE | May 2014 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Intrahepatic fat [ Time Frame: -7±3days; 168±3days ] intrahepatic fat change from baseline by quantitative ultrasound
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability [ Time Frame: -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days ] adverse events caused by the drugs
|
|||
Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | Antidiabetic Effects on Intrahepatic Fat | |||
Official Title ICMJE | Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD) | |||
Brief Summary | This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease. | |||
Detailed Description | Following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza, Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a proper diet and exercise. For the metformin group (n = 31), the dosage was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study. For the gliclazide group (n = 31), the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L. For the liraglutide group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study.At the end of the study, data will be collected and analyzed. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
87 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2015 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 17 Years to 80 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT03068065 | |||
Other Study ID Numbers ICMJE | ChiCTR-TRC-14004660 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
|
|||
Responsible Party | Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | |||
Study Sponsor ICMJE | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |