Research-led clinical trial to analyze body composition and metabolite changes after taking SGLT2i in patients receiving treatment for type 2 diabetes

Not Applicable

Recruiting

Conditions: Endocrine, nutritional and metabolic diseases

Registration Number: KCT0009571

Lead Sponsor: Jeonbuk National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Adult men and women aged 19 years or older at the time of screening
(1) For women of childbearing potential, a pregnancy test is required during screening, and only those who agree to contraception during the study participation period can participate.
(2) When elderly people over 70 years of age participate, only those who are assessed as having sufficient cognitive ability and ability to consent in a daily clinical environment are selected.
2. Those diagnosed with type 2 diabetes at the time of screening
3. Those with HbA1c of 10% or less at the time of screening
4. Patients who have not received enavogliflozin, dapagliflozin, or empagliflozin (including both single drugs or combination drugs containing the ingredients) within the scope of approval and reimbursement within 6 months
5. Patients who require administration of enavogliflozin, dapagliflozin, and empagliflozin (including both single drugs or combination drugs containing the ingredients) within the scope of approval and reimbursement
6. If the research subject or legal representative voluntarily agrees to comply with the subject's precautions during the research and participation period after receiving and understanding an independent explanation of the study and the left and right sides of the research selection

Exclusion Criteria

1. Those with diabetes other than type 2 (those who cannot be treated with oral hypotensive agents)
2. Patients with moderate to severe hepatic impairment who meet one or more of the following:
1) Aspartate transaminase (AST) or alanine transferase (ALT) level is three times the upper limit of normal
2) Total bilirubin is twice the upper limit of normal
3) Those currently suffering from hepatitis or liver failure
3. Patients with confirmed renal dysfunction as evidenced by an estimated glomerular filtration rate (eGFR) value of less than 60 mL/min/1.73m2 when starting medication (After starting medication, the medication can be maintained up to the approval for each medication)
4. Persons with the following serious comorbid health conditions:
- Those with a disease with a life expectancy of less than 4 years (Example: Patients with a history of malignant cancer, including solid tumors and lymphoma, within 5 years)
- Uncontrolled high blood pressure [systolic blood pressure (SBP)>180 mmHg or diastolic blood pressure (DBP)>100 mmHg]
- Myocardial infarction (MI) or stroke that occurred within 1 month ; Serious cardiac and cerebrovascular diseases
- According to the heart failure classification of the New York Heart Association (NYHA) class IV heart failure (HF)
5. Persons with a history of hypersensitivity to SGLT2i class drug ingredients and their constituents
6. Pregnant and lactating women
7. Those currently participating in other clinical trials
8. Those who have taken medication for the purpose of treating obesity within the past 6 months
9. Patients with uncontrolled hypothyroidism or hyperthyroidism, patients who have maintained normal TFT for more than 3 months and are taking stable doses of medication can be included.
10. If the subject has an underlying disease that may cause weight change and the disease is not controlled, and the researcher determines that the subject is inappropriate to participate in the study (ex. Cushing's syndrome, nephrotic syndrome, pheochromocytoma, etc.)
11. If the researcher determines that the subject’s participation in the study is inappropriate