Targeting liver fat with the CMNT intermittent diet for people with type 2 diabetes and fatty liver

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

This study will try a CMNT intermittent energy‑restriction diet to see if lowering liver fat helps adults with type 2 diabetes and nonalcoholic fatty liver disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: State Key Laboratory of Subhealth Intervention Technology (Academic / other)
• Locations: 3 sites (Yichang, Hubei and 2 other locations)
• Trial ID: NCT07083336 on ClinicalTrials.gov

What this trial studies

This multicenter interventional study will randomize about 120 Chinese adults with type 2 diabetes and NAFLD to a CMNT intermittent energy‑restriction diet versus usual care, with an added interim analysis to check effectiveness, safety, and compliance. Eligibility includes ages 18–75, BMI >18 kg/m2, stable weight and stable diabetes medication for at least three months. Primary outcomes focus on changes in liver fat and metabolic control, while expanded secondary analyses will include metabolomics and gut microbiome profiling and causal validation via fecal transfer experiments. The protocol expansion increased sites from 3 to 6 and removed the upper BMI limit to improve recruitment and generalizability.

Who should consider this trial

Good fit: Adults 18–75 years with diagnosed type 2 diabetes and nonalcoholic fatty liver disease, stable weight and stable diabetes medication for at least three months, and willing to follow an intermittent energy‑restriction diet are ideal candidates.

Not a fit: People with unstable or recently changed glucose‑affecting medications, recent use of systemic glucocorticoids or other metabolism‑altering drugs, major comorbidities, or inability to adhere to dietary changes are unlikely to benefit.

Why it matters

Potential benefit: If successful, the CMNT diet could reduce liver fat and improve blood sugar control, potentially lowering complications for people with type 2 diabetes and fatty liver.

How similar studies have performed: Related intermittent energy‑restriction and dietary programs have shown promise for reducing liver fat and improving glycemic control, but the specific CMNT program and its metabolomics/microbiome effects remain less tested.

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.

Where this trial is running

Yichang, Hubei and 2 other locations

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

Study contacts

• Study coordinator: Wu Luo

Conditions Type 2 Diabetes Mellitus; Metabolic Dysfunction-associated Steatotic Liver Disease; Comorbid MASLD and T2DM; Intermittent energy restriction