The effects of dapagliflozin on hepatic and visceral fat in type 2 diabetes patients with non-alcoholic fatty liver disease

Phase 4

Completed

• Conditions: on-alcoholic fatty liver diseaseDiabetes patient; NAFLD; DM type II; Insulin resistance; SGLT2 inhibitor; Fatty liver

• Registration Number: TCTR20170511001
• Lead Sponsor: The Faculty of Medicine endownment Fund

Brief Summary

Dapagliflozin treatment for 12 weeks is associated with improvement in hepatic fat content, a decrease in visceral fat and bodyweight, enhanced glycemic control, and improved liver biochemistry among T2DM patients with NAFLD.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-11
• Study Completion: 2017-12-29
• Results First Posted: 2021-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1.Age 18 -75 years
2.Patient with T2DM who are on standard medications (metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonist, alpha-glucosidase inhibitor, thiazolidinedione, in any combination) for at least 24 weeks, with stable diabetic parameters (HbA1c, FBS) and dosage
3.HbA1c more than 7.0% but less than 10.0%
4.No history of alcohol consumption of more than 10 g/d in female and 20 g/d in male in past 12 months
5.No other conditions that may lead to fatty liver by history, physical examination, and appropriate testing
6.Diagnosed NAFLD by non-contrast CT scan in past 12 months
7.The subject has provided written informed consent prior to admission the study

Exclusion Criteria

1.Presence of severe acute or chronic diseases (liver, heart, renal failure), infectious or autoimmune liver diseases (positive for hepatitis B surface antigens, anti-hepatitis C virus, anti-nuclear or anti-mitochondrial antibodies)
2.Known history or clinical evidence of liver cirrhosis
3.Known allergy to SGLT2 inhibitors medication
4.Patient with T2DM on insulin therapy
5.Taken any weight loss medications within 3 months prior to admission to the study
6.Participants treated with vitamin E in the past immediate 6 months
7.eGFR by CKD-epi method < 60 ml/min/1.73m2
8.Pregnancy and breastfeeding
9.Lake of ability or willingness to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of Dapagliflozin on improvement of NAFLD 12 weeks Liver attenuation index by Non-contrast CT scan

Secondary Outcome Measures

Name	Time	Method
Improvement of NASH and metabolic parameters 12 weeks measured all fat area, visceral fat area, subcutaneous fat area and girth by semiautomatic software ,Improvement of body composition 12 weeks Body weight, Body mass index, waist circumference, visceral fat to subcutaneous fat ratio in non-contrast CT scans,Improvement od metabolic parameter 12 weeks HOMA-IR, Leptin, adiponectin and TNF-alpha