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)

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes Mellitus, Metabolic Dysfunction-associated Steatotic Liver Disease

In brief

This study aims to explore the efficacy of CMNT, an intermittent energy restriction (iER) intervention, in managing Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease. An interim analysis will be added to the planned 120-participant CMNT intervention program to compare intervention efficacy with the usual care control group and assess potential risks associated with dietary interventions.

Key facts

Study ID

NCT07083336

Run by

State Key Laboratory of Subhealth Intervention Technology

People needed

120

Starts

2022-06-05

Expected to finish

2026-06-05

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Physical Examination Center of Gezhouba central hospital of Sinopharm — Yichang, Hubei, China (enrolling)
• Hunan Shanshui physical examination center — Changsha, Hunan, China (enrolling)
• Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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