NCT05764811

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

Mechanism of the Effect by Sodium-glucose Cotransporter-2 Inhibitor on Obesity Associated Cardiomyopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The investigators will enrolled 40 diabetes mellitus with BMI\>27 Kg/m2 patients from obesity weight-reduction clinics and will compare the variation of FGF21 related proteins between these 2 groups of subjects. Serial examinations will evaluate the possible mechanisms underlying the protective mechanism. This investigation expect that SGLT2-inhibitor can increase the concentration of FGF21 in the heart by increasing FGF21 in the liver, thereby modifying associated protein expressions and ultimately improving cardiac function and patient outcomes.

Conditions

• Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Canagliflozin 100mg	100 mg daily for a month

Timeline

• Start date: 2020-03-06
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2023-03-13
• Last updated: 2023-03-13

Locations

1 site across 1 country: Taiwan