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)

NCT07083336 | Recruiting DMC

• 1 other identifier: Version 3.0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to explore the efficacy of CMNT, an intermittent energy restriction (iER) intervention, in managing Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease. An interim analysis will be added to the planned 120-participant CMNT intervention program to compare intervention efficacy with the usual care control group and assess potential risks associated with dietary interventions.

Conditions

Type 2 Diabetes Mellitus; Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

Comorbid MASLD and T2DM; Intermittent energy restriction

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 (10)

• γ-GGT

  3, 6, 12, 24 months

• Body Mass Index (BMI)

  3, 6, 12, 24 months

• Fasting blood glucose

  3, 6, 12, 24 months

• Fasting insulin

  3, 6, 12, 24 months

• Blood lipid

  3, 6, 12, 24 months

Study Arms (2)

Experimental: 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

Experimental: CMNT diet

Eligibility Criteria

• Age: 18 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.
• Body mass index (BMI) \> 18.0 kg/m2
• Weight stable for at least 3 months prior to the study (gain or loss \<4kg).
• Stable treatment for at least 3 months with 1-3 oral
• antidiabetic medications (with or without insulin therapy), or not yet receiving antidiabetic medication prior to the beginning of the study.
• Able to give written informed consent.

You may not qualify if:

• Participants meeting any of the following criteria will not be allowed to participate in the trial:
• Use of any of the following medications or treatments:
• Use of other medications that may affect glucose metabolism within the past 2 months, including systemic glucocorticoids (excluding inhaled or topical use), growth hormones, etc.;
• Use of antihypertensive or lipid-lowering medications that have not reached a stable dosage before screening;
• Presence of any of the following medical histories or conditions:
• History or presence of any cardiac disease within the past 6 months;
• Decompensated heart failure (NYHA Class III or IV);
• Unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stenting;
• Uncontrolled or severe arrhythmias (e.g., long QT syndrome), as assessed by the investigator as unsuitable for trial participation;
• History of hemorrhagic or ischemic stroke within the past 6 months, as assessed by the investigator as unsuitable for trial participation;
• Medical history of cerebral thrombosis, cerebral vascular blockage, encephalic angioma, transient ischemic attack, cerebral hemorrhage, stroke, hydrocephalus, or malignant brain tumor;
• History of carotid artery stenting;
• Urinary system conditions such as nephrotic syndrome, uremia, polycystic kidney disease, kidney transplantation, unilateral nephrectomy/congenital solitary kidney, renal atrophy, renal tumor;
• Digestive system conditions such as ascites, liver cirrhosis, liver fluke infection, severe hepatitis, gastric varices;
• Nervous system conditions such as cerebellar atrophy, demyelinating diseases, cerebral palsy, Parkinson's disease, mania, schizophrenia;

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

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

Wu Luo

CONTACT

+86-0731-8461-5293; luowubio@163.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: July 8, 2025
• First Posted: July 24, 2025
• Study Start: June 5, 2022
• Primary Completion: May 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)