Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449833
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-15
Brief Title:
Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease A Multicenter Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HHTN
Brief Summary:
This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus DM and nonalcoholic fatty liver disease NAFLD Sponsored by Zhujiang Hospital of Southern Medical University this study is a multi-center randomized controlled clinical trial aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 11 ratio and subsequently initiate the intervention period of 24 weeks In this trial patients will be treated with 10 mg of Henagliflozein metformin and 5 mg of Linagliptin metformin as control and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level The check-points are set at the 8th 16th and 24th week of the follow-up after the treatment and nutritionists are available to provide dietary and exercise guidance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None