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

NCT05764811 | Completed

• 1 other identifier: A-BR-108-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatty Liver Disease

Keywords

fatty liver; diabetes mellitus; SGLT2 inhibitor

Outcome Measures

Primary Outcomes (1)

• measure the severity of fatty liver via MRI

  The fibrotic score and severity by MRI of the liver will be performed before and after the treatment. The measurement of fatty liver requires both in-phase (IP) and out-of-phase (OOP) imaging to be adequately assessed. Fatty liver appears: T1: hyperintense, T2: mildly hyperintense, IP/OOP imaging: signal drop out on OOP imaging On IP/OOP imaging, signal loss is demonstrated when there is 10-15% fat fraction with maximum signal loss occurring when there is 50% fatty infiltration of the liver. In situations in which there is \>50% fatty infiltration, the out-of-phase sequence paradoxically becomes less hypointense than at 50%.

  4 weeks

Secondary Outcomes (3)

• measure the body weight before and after the treatment

  4 weeks

• measure the body height before and after the treatment

  4 weeks

• measure the body mass index (BMI) before and after the treatment

  4 weeks

Study Arms (2)

Canagliflozin Treatment

ACTIVE COMPARATOR

Use Canagliflozin 100 mg daily, 1 month

Drug: Canagliflozin 100mg

non-Canagliflozin Treatment

NO INTERVENTION

Standard treatment

Interventions

Canagliflozin 100mg DRUG

100 mg daily for a month

Also known as: standard of care

Canagliflozin Treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 20 years of age
• With diagnosis of diabetic mellitus (HbA1C≧6.5%) by medical record or physicians
• BMI ≧ 27 kg/m2, which is the current definition of obesity from Health Promotion Administration, Ministry of Health and Welfare.

You may not qualify if:

• Unwilling to participating current clinical trial
• Cannot tolerate SGLT2-i therapy
• Not willing to join the study
• History of failure treatment experience from SGLT2-i or other weight reduction plan
• Received pharmaceutical or clinical trials within past 1 year

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Diabetes Mellitus

Interventions

Canagliflozin; Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ping-Yen Liu

  National Cheng-Kung University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor/Professor

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 13, 2023
• Study Start: March 6, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)