Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
About this study
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.
- Condition
- Type 2 Diabetes
- Tested
- CMNT diet
- Sponsor
- State Key Laboratory of Subhealth Intervention Technology
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Type 2 Diabetes
- 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 11
- 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
3 sites, 3 recruiting
Hunan Shanshui physical examination center
Changsha, Hunan, China
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, Hunan, China
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, Hubei, China
Contact
-
Luo wu
13687333270 luowubio@163.com
-
Yang xiao
15200877395 31884210@qq.com
Potential match only. Final eligibility is determined by the study team.