Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
Recruiting · NCT05439226 · Interventional (participants receive a specific treatment) · Lead sponsor: State Key Laboratory of Subhealth Intervention Technology
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Previous study showed that a Chinese medical nutrition therapy (CMNT) diet, which intermittent use of low-calorie medicinal food, has a glucose-lowering effect in T2D. This study aims to investigate the effect of a Chinese medical nutrition therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated hemoglobin (HbA1c) in patients with T2D and NAFLD.
Who can take part
Inclusion criteria
- Patients diagnosed with type 2 diabetes and NAFLD
- Age between 18 and 75 years
- BMI between 18.0 and 35.0 kg/m2
- Weight stable for at least 3 months prior to the study (gain or loss \< 4 kg)
- Stable treatment for at least 3 months with 1-3 oral antidiabetic medications (with or without insulin therapy), or not yet received antidiabetic medication prior to the beginning of the study
- Able to give written informed consent
Exclusion criteria
- Self-reported a food allergy
- Alcohol abuse in the last 3 months (alcohol intake greater than 20 g per day for women; Alcohol intake for men greater than 40 g per day)
- Other liver diseases such as chronic hepatitis B and C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, nodular regenerative hyperplasia and focal nodular hyperplasia
- Scheduled to be hospitalized for any surgical treatment during screening
- Pregnant or planning of pregnancy during the study
- Inability, physically or mentally, to adhere the procedures required by the study protocol
- Level 3 hypoglycemic events (at least 3 times) occurring within the 90 days prior to screening
- Hospitalization or emergency department visit for hyperglycemia, diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic coma, or diabetes
- History of cancer within the past 5 years
- Acute coronary or cerebrovascular event in the past 90 days, or heart failure
- Hemorrhagic or ischemic stroke within the last 6 months
Where it is running
3 locations listed.
- Physical Examination Center of Gezhouba central hospital of Sinopharm - Yichang, Hubei, China
- Hunan Shanshui physical examination center - Changsha, Hunan, China
- Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center - Changsha, Hunan, China