Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease (Version 3.0)

Korábbi kezelés

• Use of any of the following medications or treatments:
• Use of antihypertensive or lipid-lowering medications that have not reached a stable dosage before screening;

Más betegség

• Presence of any of the following medical histories or conditions:
• History or presence of any cardiac disease within the past 6 months;
• Decompensated heart failure (NYHA Class III or IV);
• Unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stenting;
• History of hemorrhagic or ischemic stroke within the past 6 months, as assessed by the investigator as unsuitable for trial participation;
• Medical history of cerebral thrombosis, cerebral vascular blockage, encephalic angioma, transient ischemic attack, cerebral hemorrhage, stroke, hydrocephalus, or malignant brain tumor;
• History of carotid artery stenting;
• Urinary system conditions such as nephrotic syndrome, uremia, polycystic kidney disease, kidney transplantation, unilateral nephrectomy/congenital solitary kidney, renal atrophy, renal tumor;
• Digestive system conditions such as ascites, liver cirrhosis, liver fluke infection, severe hepatitis, gastric varices;
• Nervous system conditions such as cerebellar atrophy, demyelinating diseases, cerebral palsy, Parkinson's disease, mania, schizophrenia;
• Respiratory system conditions such as pulmonary embolism, cor pulmonale;
• Musculoskeletal system conditions such as arterial rupture, myeloma;
• Immune system conditions such as Behçet's disease, lupus erythematosus;
• Conditions such as chondrosarcoma, liposarcoma, brucellosis, leukemia;
• History of malignant tumor within the past 5 years, or currently under evaluation for potential malignancy;
• History of unstable or treatment-requiring proliferative retinopathy or macular edema within the past 6 months;
• History of diabetic ketoacidosis or hyperosmolar nonketotic diabetic coma within the past 6 months;
• Currently suffering from lower extremity arteriosclerotic occlusive disease; History of severe infection or severe trauma within the past 1 month;
• History of ≥2 severe hypoglycemic episodes within the past year;
• Currently suffering from clinically significant urinary tract/genital infection, or a history of complicated urinary tract infections, or recurrent urinary tract infections within the past 6 months;
• Currently suffering from uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening/baseline, or systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg;
• History of other severe endocrine diseases, such as multiple endocrine neoplasia;
• History of severe hepatic or renal disease;
• Suspected or confirmed history of alcohol or drug abuse;
• Presence of severe psychiatric disorders or language barriers, unwillingness or inability to fully understand and cooperate;
• Any other conditions deemed unsuitable for trial participation by the investigator.

Laborértékek

• Use of other medications that may affect glucose metabolism within the past 2 months, including systemic glucocorticoids (excluding inhaled or topical use), growth hormones, etc.;
• Uncontrolled or severe arrhythmias (e.g., long QT syndrome), as assessed by the investigator as unsuitable for trial participation;

Egyéb

• Participants meeting any of the following criteria will not be allowed to participate in the trial:
• Currently suffering from uncontrolled thyroid dysfunction;
• Blood donation or blood loss ≥400 mL within the past 3 months;
• Pregnant or breastfeeding women;

• Patients diagnosed with type 2 diabetes and NAFLD.
• Age between 18 and 75 years.
• Body mass index (BMI) > 18.0 kg/m2
• Weight stable for at least 3 months prior to the study (gain or loss <4kg).
• Stable treatment for at least 3 months with 1-3 oral
• antidiabetic medications (with or without insulin therapy), or not yet receiving antidiabetic medication prior to the beginning of the study.
• Able to give written informed consent.