Type 2 diabetes complicated by non-alcoholic fatty liver disease
Conditions
Interventions
CMNT intervention group:Using a 15-day cycle, the first 5 days replace the main meals of lunch and dinner in daily life with the CMNT nutrition intervention package, followed by a return to the origin
Conventional lifestyle intervention group:According to the usual dietary habits of consuming staple food, the intervention will be provided with nutritional recipe suggestions from the health coach th
Sponsors
Central Hospital of Yiyang City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: This research plan includes individuals aged 18 to 75 years (including 18 and 75 years), regardless of gender; participants must be diagnosed with type 2 diabetes according to the standards established by the World Health Organization in 1999 and have fatty liver (which can be determined from the volunteer's past medical records or previous preliminary screening with ultrasound). The body mass index (BMI) at screening should be between 20.0 and 35.0 kg/m^2 (inclusive of both ends); participants should have a strong desire to improve their physical condition, be able to understand and comply with the trial procedures, volunteer for the trial, and provide informed consent. A total of 90 people.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be allowed to participate in this trial: 1. Patients known at screening to plan hospitalization for any surgical treatment. (1) Patients allergic to food components related to CMNT. (2) Recurrent (>=3 times) grade 3 hypoglycemic events within 90 days prior to screening. (3) Type 1 diabetes, diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly). (4) Laboratory test results meet any of the following criteria: calcitonin >=50 ng/L (pg/mL), serum amylase >=3×ULN, triglycerides >=5.7 mmol/L (500 mg/dL), eGFR =2.5×ULN, AST >=2.5×ULN, total bilirubin >=2×ULN. 2. Receiving any of the following medications or treatments: (1) Used other drugs that may affect glucose metabolism within the past 2 months, including patients on hormone replacement therapy such as systemic corticosteroids (excluding inhaled or topical), growth hormone, etc. (2) Taking antihypertensive or lipid-lowering drugs, but the dose has not reached a stable state prior to screening. (3) Participated in other clinical nutrition intervention trials or other clinical new drug trials within 3 months prior to screening. 3. Any of the following medical histories or conditions: (1) History or condition of any of the following heart diseases within the last 6 months (2) Decompensated heart failure (NYHA class III or IV). (3) Heart failure (NYHA class IV), acute coronary syndrome, or cerebrovascular events within 90 days prior to screening (excluding old lacunar infarcts), including but not limited to acute myocardial infarction, unstable angina, stroke/TIA, or cardiac-related surgery within 90 days prior to screening (including coronary artery bypass grafting, percutaneous coronary intervention), or ECG abnormalities assessed by the investigator as severe. (4) Uncontrolled hypertension (defined as systolic BP >=160 mmHg and/or diastolic BP >=100 mmHg) or other cardiovascular or cerebrovascular diseases unsuitable for participation. (5) Hemorrhagic or ischemic stroke within the last 6 months, and assessed by the investigator as unsuitable for participation; presence of cerebral thrombosis, cerebrovascular blockage, cerebral aneurysm, minor stroke, cerebral hemorrhage, stroke, cerebral infarction, hydrocephalus, malignant brain tumors, etc.; history of carotid artery stent implantation. (6) Urinary system disorders such as nephrotic syndrome, uremia, polycystic kidney disease, kidney transplant, nephrectomy/congenital single kidney, renal atrophy, renal tumor. (7) Digestive system disorders such as ascites, liver cirrhosis, hepatic fluke infection, or severe hepatitis. (8) Diabetic gastroparesis or other gastrointestinal motility disorders (such as pyloric obstruction, intestinal obstruction, postoperative gastroparesis, idiopathic gastroparesis, etc.); (9) Neurological conditions such as cerebellar atrophy, demyelination, cerebral palsy, Parkinson's disease, mania, schizophrenia; (10) Respiratory conditions such as pulmonary embolism, cor pulmonale; (11) Musculoskeletal conditions such as arterial rupture, multiple myeloma; (12) Immune system conditions such as Behçet's disease, lupus erythematosus rash; (13) Conditions such as chondrosarcoma, liposarcoma, brucellosis, leukemia; (14) History of mal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c);Liver fat content;C-reactive protein (hCRP); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Fasting insulin;Four-item lipid profile (TG, TC, HDL-C, LDL-C);Alanine Aminotransferase / Aspartate Aminotransferase;Gamma-glutamyl transferase;Basic measurements: height, weight, blood pressure, heart rate, chest circumference, waist circumference, hip circumference;Quality of life;Treatment satisfaction; | — |
Countries
China
Contacts
Public ContactPeng Weixia
Central Hospital of Yiyang City
Outcome results
None listed