Clinical trial NCT05439226: Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
Official title: Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes with NAFLD
CMNT diet
Lead sponsor: State Key Laboratory of Subhealth Intervention Technology
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Controlled attenuation parameter (CAP) value by transient elastography
timeFrame: 3, 6, 12, 24 months
measure: HbA1C
timeFrame: 3, 6, 12, 24 months
Secondary outcomes:
measure: Fatty liver index (FLI)
timeFrame: 3, 6, 12, 24 months
measure: Hepatic steatosis index (HSI)
timeFrame: 3, 6, 12, 24 months
measure: Liver stiffness measurement (LSM) value by transient elastography
timeFrame: 3, 6, 12, 24 months
measure: Fibrosis-4 index (FIB-4)
timeFrame: 3, 6, 12, 24 months
measure: NAFLD fibrosis score (NFS)
timeFrame: 3, 6, 12, 24 months
measure: Liver function test
timeFrame: 3, 6, 12, 24 months
measure: Blood glucose
timeFrame: 3, 6, 12, 24 months
measure: Blood lipid
timeFrame: 3, 6, 12, 24 months
measure: Insulin
timeFrame: 3, 6, 12, 24 months
measure: HOMA-IR
timeFrame: 3, 6, 12, 24 months
measure: IGF-1
timeFrame: 3, 6, 12, 24 months
measure: Body mass index
timeFrame: 3, 6, 12, 24 months
measure: waist-to-hip ratio
timeFrame: 3, 6, 12, 24 months
measure: Blood pressure
timeFrame: 3, 6, 12, 24 months
measure: Energy intake
timeFrame: 3, 6, 12, 24 months
measure: Macronutrient intake
timeFrame: 3, 6, 12, 24 months
measure: Sleep quality
timeFrame: 3, 6, 12, 24 months
measure: Physical activity
timeFrame: 3, 6, 12, 24 months
measure: Self-reported depressive symptoms
timeFrame: 3, 6, 12, 24 months
measure: Anxiety symptoms
timeFrame: 3, 6, 12, 24 months
measure: Social support
timeFrame: 3, 6, 12, 24 months
measure: Reduction in glucose-lowering medication
timeFrame: 3, 6, 12, 24 months
measure: Fecal microbiota profile
timeFrame: 3, 6, 12, 24 months
measure: Metabolomics
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Yichang
country: China
facility: Physical Examination Center of Gezhouba central hospital of Sinopharm
state: Hubei
city: Changsha
country: China
facility: Hunan Shanshui physical examination center
state: Hunan
city: Changsha
country: China
facility: Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
state: Hunan
Study officials:
References: