Phase
Condition
Primary Biliary Cholangitis
Diabetes Prevention
Diabetes And Hypertension
Treatment
CMNT diet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 receivingantidiabetic medication prior to the beginning of the study.
Able to give written informed consent.
Exclusion
Exclusion Criteria:
Participants meeting any of the following criteria will not be allowed toparticipate in the trial:
Use of any of the following medications or treatments:
Use of other medications that may affect glucose metabolism within the past 2months, including systemic glucocorticoids (excluding inhaled or topical use),growth hormones, etc.;
Use of antihypertensive or lipid-lowering medications that have not reached a stabledosage 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 coronarystenting;
Uncontrolled or severe arrhythmias (e.g., long QT syndrome), as assessed by theinvestigator as unsuitable for trial participation;
History of hemorrhagic or ischemic stroke within the past 6 months, as assessed bythe investigator as unsuitable for trial participation;
Medical history of cerebral thrombosis, cerebral vascular blockage, encephalicangioma, transient ischemic attack, cerebral hemorrhage, stroke, hydrocephalus, ormalignant brain tumor;
History of carotid artery stenting;
Urinary system conditions such as nephrotic syndrome, uremia, polycystic kidneydisease, 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 evaluationfor potential malignancy;
History of unstable or treatment-requiring proliferative retinopathy or macularedema within the past 6 months;
History of diabetic ketoacidosis or hyperosmolar nonketotic diabetic coma within thepast 6 months;
Currently suffering from lower extremity arteriosclerotic occlusive disease; Historyof 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, ora history of complicated urinary tract infections, or recurrent urinary tractinfections within the past 6 months;
Currently suffering from uncontrolled hypertension, defined as systolic bloodpressure ≥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 orinability to fully understand and cooperate;
Pregnant or breastfeeding women;
Any other conditions deemed unsuitable for trial participation by the investigator.
Study Design
Study Description
Connect with a study center
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, Hubei
ChinaActive - Recruiting
Hunan Shanshui physical examination center
Changsha, Hunan
ChinaActive - Recruiting
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, Hunan
ChinaActive - Recruiting

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