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)

Launched by STATE KEY LABORATORY OF SUBHEALTH INTERVENTION TECHNOLOGY · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special diet called the Chinese Medical Nutrition Therapy (CMNT) diet, which uses a pattern of eating called intermittent energy restriction. The goal is to see if this diet can help adults in China who have both type 2 diabetes and a liver condition called non-alcoholic fatty liver disease (NAFLD), where fat builds up in the liver. The study will compare people following the CMNT diet with those receiving usual care to find out how well the diet manages these health issues and to check for any risks.

People eligible to join this study are adults between 18 and 75 years old who have both type 2 diabetes and fatty liver disease, with a stable body weight and treatment plan for diabetes. Participants should be taking 1 to 3 oral diabetes medications, with or without insulin, or not yet on medication. Those with serious heart, kidney, liver, or other health problems, pregnant or breastfeeding women, and people using certain medications or with recent severe health events won’t be able to participate. If you join, you can expect to follow the CMNT diet or continue usual care while researchers monitor your health, including your liver fat and blood sugar levels, to see how well the diet works. This study is currently recruiting participants and aims to help find better ways to manage diabetes and liver health through diet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• * Participants meeting any of the following criteria will not be allowed to participate in the trial:
• * Use of any of the following medications or treatments:
• • 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.;
• • Use of antihypertensive or lipid-lowering medications that have not reached a stable dosage before screening;
• * 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;
• • Uncontrolled or severe arrhythmias (e.g., long QT syndrome), as assessed by the investigator as unsuitable for trial participation;
• • 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;
• • Currently suffering from uncontrolled thyroid dysfunction;
• • 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;
• • Blood donation or blood loss ≥400 mL within the past 3 months;
• • Presence of severe psychiatric disorders or language barriers, unwillingness or inability to fully understand and cooperate;
• • Pregnant or breastfeeding women;
• • Any other conditions deemed unsuitable for trial participation by the investigator.