Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
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

Led by State Key Laboratory of Subhealth Intervention Technology · Updated on 2025-07-25

120

Participants Needed

3

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Physical Examination Center of Gezhouba central hospital of Sinopharm

Yichang, Hubei, China

Actively Recruiting

2

Hunan Shanshui physical examination center

Changsha, Hunan, China

Actively Recruiting

3

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

Changsha, Hunan, China

Actively Recruiting

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Research Team

L

Luo wu

CONTACT

Y

Yang xiao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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