Clinical Trials in China / NCT07083336
Recruiting
Not applicable
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)
NCT07083336 · tracked via the Priya Life Science China tracker
Condition(s) studied
Type 2 Diabetes MellitusMetabolic Dysfunction-associated Steatotic Liver Disease
Investigational drug(s) / intervention(s)
CMNT diet
CMNT diet: Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Controlled attenuation parameter (CAP) value by transient elastography — 3, 6, 12, 24 months
The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP \< 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP \> 291 dB/m denoted severe steatosis. - HbA1C — 3, 6, 12, 24 months
Blood test to measure glucose control
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Physical Examination Center of Gezhouba central hospital of Sinopharm | Yichang | Hubei | Recruiting |
| Hunan Shanshui physical examination center | Changsha | Hunan | Recruiting |
| Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center | Changsha | Hunan | Recruiting |
More State Key Laboratory of Subhealth Intervention Technology trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07083336 on ClinicalTrials.gov ↗ ← All trials in China