Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- HbA1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HbA1C
时间窗: 3, 6, 12, 24 months
Blood test to measure glucose control
Controlled attenuation parameter (CAP) value by transient elastography
时间窗: 3, 6, 12, 24 months
The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP \< 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP \> 291 dB/m denoted severe steatosis.
次要结局
- Fatty liver index (FLI)(3, 6, 12, 24 months)
- Hepatic steatosis index (HSI)(3, 6, 12, 24 months)
- Fibrosis-4 index (FIB-4)(3, 6, 12, 24 months)
- NAFLD fibrosis score (NFS)(3, 6, 12, 24 months)
- HOMA-IR(3, 6, 12, 24 months)
- IGF-1(3, 6, 12, 24 months)
- Liver stiffness measurement (LSM) value by transient elastography(3, 6, 12, 24 months)
- Liver function test(3, 6, 12, 24 months)
- Reduction in glucose-lowering medication(3, 6, 12, 24 months)
- Body mass index(3, 6, 12, 24 months)
- waist-to-hip ratio(3, 6, 12, 24 months)
- Blood pressure(3, 6, 12, 24 months)
- Energy intake(3, 6, 12, 24 months)
- Anxiety symptoms(3, 6, 12, 24 months)
- Social support(3, 6, 12, 24 months)
- Fecal microbiota profile(3, 6, 12, 24 months)
- Metabolomics(3, 6, 12, 24 months)
- Blood lipid(3, 6, 12, 24 months)
- Macronutrient intake(3, 6, 12, 24 months)
- Blood glucose(3, 6, 12, 24 months)
- Insulin(3, 6, 12, 24 months)
- Sleep quality(3, 6, 12, 24 months)
- Physical activity(3, 6, 12, 24 months)
- Self-reported depressive symptoms(3, 6, 12, 24 months)