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

Обзор

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.

Подробное описание

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 Grosvenori, Folium Mori, Radix Puerariae, Fructus lycii, Poria cocos that meets the requirements of a food for special medical purpose. The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle. CMNT diet is composed of four ready-to-consume prepared foods including composite nutritional rice, solids beverages, meal replacement biscuit and fruit and vegetable gruel mainly from wholegrains and traditional Chinese medicinal food plants. The intervention lasted for 3 months (6 cycles) and follow-up measurements will be performed in all subjects after 3-months from end of the intervention. The glucose-lowering medication use of participants strictly implemented by their physician according to the diabetes medications management protocol. Treatment-as-usual control group continued to be given standard medication and dietary advice by their physician followed guidelines for the prevention and control of T2D in China.

Вмешательства

• Другое CMNT diet
  Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet

Первичные конечные точки

• Controlled attenuation parameter (CAP) value by transient elastography [Срок оценки: 3, 6, 12, 24 months]
• HbA1C [Срок оценки: 3, 6, 12, 24 months]

Вторичные конечные точки (12)

• Fatty liver index (FLI) [Срок оценки: 3, 6, 12, 24 months]
• Hepatic steatosis index (HSI) [Срок оценки: 3, 6, 12, 24 months]
• Liver stiffness measurement (LSM) value by transient elastography [Срок оценки: 3, 6, 12, 24 months]
• Fibrosis-4 index (FIB-4) [Срок оценки: 3, 6, 12, 24 months]
• NAFLD fibrosis score (NFS) [Срок оценки: 3, 6, 12, 24 months]
• Liver function test [Срок оценки: 3, 6, 12, 24 months]
• Blood glucose [Срок оценки: 3, 6, 12, 24 months]
• Blood lipid [Срок оценки: 3, 6, 12, 24 months]
• Insulin [Срок оценки: 3, 6, 12, 24 months]
• HOMA-IR [Срок оценки: 3, 6, 12, 24 months]
• IGF-1 [Срок оценки: 3, 6, 12, 24 months]
• Body mass index [Срок оценки: 3, 6, 12, 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Physical Examination Center of Gezhouba central hospital of Sinopharm — Yichang
• Hunan Shanshui physical examination center — Чанша
• Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement A — Чанша

Публикации

• Luo W, Xiao Z, Yang X, Wu R, Li J, Yu Z, Guo S, Nie B, Liu D. Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial. BMJ Open. 2024 Apr 29;14(4):e081263. doi: 10.1136/bmjopen-2023-081263. PMID 38684277

Идентификаторы

NCT: NCT05439226 · Version 2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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