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

NCT05439226 · tracked via the Priya Life Science China tracker

Sponsor

State Key Laboratory of Subhealth Intervention Technology

Phase

Not applicable

Started

2022-07-05

Last updated

2025-07-25

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

CMNT diet

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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 outcome measure(s)

Controlled attenuation parameter (CAP) value by transient elastography — 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.
HbA1C — 3, 6, 12, 24 months
Blood test to measure glucose control

Trial sites (3)

Facility	City	Region	Status
Physical Examination Center of Gezhouba central hospital of Sinopharm	Yichang	Hubei	Recruiting
Hunan Shanshui physical examination center	Changsha	Hunan	Recruiting
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center	Changsha	Hunan	Recruiting

More State Key Laboratory of Subhealth Intervention Technology trials in China

Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease (Version 3.0) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05439226 on ClinicalTrials.gov ↗ ← All trials in China