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Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease

RecruitingNAAges 18 Years - 75 YearsAllState Key Laboratory of Subhealth Intervention Teโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • CMNT diet
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Where

3 sites
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, China
Hunan Shanshui physical examination center
Changsha, China
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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