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 | Recruiting DMC

• 1 other identifier: Version 2.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes with NAFLD; CMNT diet

Outcome Measures

Primary Outcomes (2)

• Controlled attenuation parameter (CAP) value by transient elastography

  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.

  3, 6, 12, 24 months

• HbA1C

  Blood test to measure glucose control

  3, 6, 12, 24 months

Secondary Outcomes (24)

• Fatty liver index (FLI)

  3, 6, 12, 24 months

• Hepatic steatosis index (HSI)

  3, 6, 12, 24 months

• Liver stiffness measurement (LSM) value by transient elastography

  3, 6, 12, 24 months

• Fibrosis-4 index (FIB-4)

  3, 6, 12, 24 months

• NAFLD fibrosis score (NFS)

  3, 6, 12, 24 months

Study Arms (2)

CMNT diet

EXPERIMENTAL

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

Other: CMNT diet

Usual Care

NO INTERVENTION

Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group

Interventions

CMNT diet OTHER

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

CMNT diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State Key Laboratory of Subhealth Intervention Technology: lead

Study Sites (3)

Physical Examination Center of Gezhouba central hospital of Sinopharm

Yichang, Hubei, China

RECRUITING

Hunan Shanshui physical examination center

Changsha, Hunan, China

RECRUITING

Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center

Changsha, Hunan, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Luo wu

CONTACT

13687333270; luowubio@163.com

Yang xiao

CONTACT

15200877395; 31884210@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 30, 2022
• Study Start: July 5, 2022
• Primary Completion: May 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)