Effect of Canagliflozin on liver steatosis in obese non diabetic patients with non-alcoholic fatty liver disease: A double blind randomized controlled trial

Phase 3

Completed

• Conditions: on- alcoholic fatty liver disease; Non- alcoholic Fatty Liver Disease; Obesity; Canagliflozin

• Registration Number: TCTR20190118008
• Lead Sponsor: Ratchadaphiseksomphot Endowment Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-18
• Study Completion: 2020-03-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Age 18-80 years old
2. BMI 25-35 kg/m2
3. Evidence of hepatic steatosis by imaging (ultrasound, CT or MRI)
4. CAP values above 200 dB/m

Exclusion Criteria

1.Evidence of liver cirrhosis by ultrasound or Fibroscan (LSM > 12 kPa)
2.Estimated GFR < 45 ml/min/1.73m2
3.Type2 diabetes mellitus
4.SBP<90 mmHg
5.Male patients with alcohol consumption >30g/day and female patients with alcohol consumption >20g/day using AUDIT, Skinner alcohol question
6.Chronic B viral hepatitis or evidence of previous infection, chronic C viral hepatitis, autoimmune liver disease, hemochromatosis, Wilson's disease and other liver diseases
7.Exposure to drug induced steatohepatitis with in the previous 6 months: Aspirin, Amiodarone, Chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase, irinotecan), Cocaine, Glucocorticoids, Methotrexate, Nucleoside reverse transcriptase inhibitors (NRTI), Tetracycline (Intravenous administration of high doses), Total parenteral nutrition, and Valproic acid
8.Weight gain or loss ≥5 kg in last 6 months
9.Current or previous use following drugs within the past 6 months: SGLT2 inhibitor, pioglitazone, vitamin E, and liraglutide
10.Patient underwent bariatric surgery within 5 years
11.History of diabetic ketoacidosis
12.History of peripheral arterial disease or lower limb amputation
13.History of recurrent urinary tract infection
14.History of fungal infection in genital area
15.Documented genitourinary tract structural abnormality
16.Pregnant women or nursing mothers
17.Patients do not provide a written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Controlled Attenuation Parameter (CAP) at start and end of study Fibroscan (db/m)

Secondary Outcome Measures

Name	Time	Method
liver stiffness at start and end of study kPa,NAFLD fibrosis score at start, 3 months and end of study Calculation from parameters,Fibrosis-4 (FIB-4) Index at start, 3 months and end of study Calculation from parameters