NCT05764811

SGLT-2 Inhibitor Effects on Cardiac and Hepatic Metabolic Profiles for the Diabetes Patients Combined With Obesity

Completed NA Last updated 13 March 2023

What this trial tests

NA trial testing Canagliflozin 100mg in Fatty Liver Disease in 40 participants. Completed in 31 December 2022.

Timeline

6 March 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	6 March 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• Canagliflozin 100mg — full drug profile →

Conditions studied

• Fatty Liver Disease — all drugs for Fatty Liver Disease →

Sponsor

National Cheng-Kung University Hospital

Who can join

20 and older, any sex, with Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity is closely associated with an increased risk of cardiomyopathy because of the high metabolic activity of excessive fat while effective treatment of obesity-related cardiomyopathy is currently unsolved. Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) are a class of diabetic medications. Besides improving glucose control, SGLT2-i has been shown to be able to reduce the bodyweight as well as the mortality and hospitalization rates for heart failure and cardiovascular disease in the type 2 diabetes patients. It has been proposed that the heart protection by SGLT2-i might be caused by modulating the production of adipokine and cytokine. The investigators will enrolled 40 patients (diabetes mellitus with BMI\>27 Kg/m2) from obesity weight-reduction clinics: 1) 20 patients treated with SGLT2-i (CANA) and regular weight-reduction plan; 2) 20 patients with regular weight reduction plan, without CANA, for 4 weeks. The investigators will compare the variation of Fibroblast growth factor-21 (FGF21) related proteins and RNA between these 2 groups of subjects. The investigators will arrange cardiac ultrasound, hepatic MRI and fibroscan, body composition dual energy x-ray absorptiometry to evaluate the possible mechanisms underlying the liver and heart modification process, as a scientific basis for precision medicine in the future. Conclusions: SGLT2-i treatment may increase the concentration of FGF21, either in the liver or heart, thus to protect the high-fat diet induced obesity associated heart dysfunction by activating FGF21 downstream protein expression.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketone body metabolism and cardiometabolic implications for cognitive health.
   Fulghum K, Salathe SF, Davis X, Thyfault JP, et al · · 2024 · cited 11× · PMID 40093558 · DOI 10.1038/s44324-024-00029-y
2. Canagliflozin Orchestrates the Hepato-Cardiac Protection Axis via Upregulation of Liver-Derived FGF21: A Study in Mice and a Randomized Controlled Trial
   Tsai Z, Lee C, Huang T, Vairaperumal T, et al · · 2026 · DOI 10.21203/rs.3.rs-9286602/v1