Actively Recruiting
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)
Led by State Key Laboratory of Subhealth Intervention Technology · Updated on 2025-07-24
120
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with type 2 diabetes and non-alcoholic fatty liver disease.
- Age between 18 and 75 years.
- Body mass index (BMI) greater than 18.0 kg/m2.
- Stable weight for at least 3 months prior to the study with less than 4 kg gain or loss.
- Stable treatment for at least 3 months with 1-3 oral antidiabetic medications, with or without insulin, or not yet receiving antidiabetic medication.
- Able to give written informed consent.
You will not qualify if you...
- Use of medications affecting glucose metabolism within the past 2 months, including systemic glucocorticoids (except inhaled or topical) and growth hormones.
- Use of antihypertensive or lipid-lowering medications not at a stable dose before screening.
- History or presence of cardiac disease within the past 6 months, including decompensated heart failure, unstable angina, myocardial infarction, coronary artery surgery or stenting.
- Uncontrolled or severe arrhythmias.
- History of stroke or serious brain conditions within the past 6 months.
- Urinary system diseases such as nephrotic syndrome, uremia, or kidney transplant.
- Digestive system diseases including ascites, liver cirrhosis, severe hepatitis, or gastric varices.
- Nervous system disorders like cerebellar atrophy, demyelinating diseases, Parkinson's disease, mania, or schizophrenia.
- Respiratory conditions like pulmonary embolism or cor pulmonale.
- Musculoskeletal conditions such as arterial rupture or myeloma.
- Immune system diseases including Behçet's disease or lupus erythematosus.
- Certain infections and cancers or history of malignant tumors within 5 years.
- Severe diabetic eye disease or diabetic coma within 6 months.
- Severe infection or trauma within 1 month.
- History of two or more severe hypoglycemic episodes in the past year.
- Significant urinary tract or genital infections.
- Uncontrolled hypertension or thyroid dysfunction.
- Severe endocrine, hepatic, or renal diseases.
- History or suspicion of alcohol or drug abuse.
- Blood donation or loss of 400 mL or more in the past 3 months.
- Severe psychiatric disorders or inability to cooperate.
- Pregnant or breastfeeding women.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, Hubei, China
Actively Recruiting
2
Hunan Shanshui physical examination center
Changsha, Hunan, China
Actively Recruiting
3
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, Hunan, China
Actively Recruiting
Research Team
W
Wu Luo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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