Status:
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
Lead Sponsor:
State Key Laboratory of Subhealth Intervention Technology
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 wi...
Detailed Description
Diet composition of CMNT is a multicomponent Chinese medicinal food, which mainly enriched with whole grains and edible medicine and food homologous (MFH) plants such as Rhizoma Dioscoreae, Momordica ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05439226
Start Date
July 5 2022
End Date
June 5 2026
Last Update
July 25 2025
Active Locations (3)
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1
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, Hubei, China
2
Hunan Shanshui physical examination center
Changsha, Hunan, China
3
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, Hunan, China