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

A-BR-108-103

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.

2020-03-06

2022-12-31

2022-12-31

Completed

40

Inclusion Criteria: 1. Age\> 20 years of age 2. With diagnosis of diabetic mellitus (HbA1C≧6.5%) by medical record or physicians 3. BMI ≧ 27 kg/m2, which is the current definition of obesity from Health Promotion Administration, Ministry of Health and Welfare. Exclusion Criteria: 1. Unwilling to participating current clinical trial 2. Cannot tolerate SGLT2-i therapy 3. Not willing to join the study 4. History of failure treatment experience from SGLT2-i or other weight reduction plan 5. Received pharmaceutical or clinical trials within past 1 year

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-03-13