Dietary intervention using Chinese medical nutrition therapy for type 2 diabetes with liver fat issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a Chinese medical nutrition therapy (CMNT) diet on patients with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). Participants will follow a structured diet consisting of low-calorie medicinal foods for five consecutive days, followed by ten days of regular food consumption, repeated over three months. The primary goals are to reduce liver fat and lower glycated hemoglobin (HbA1c) levels. The study compares the CMNT diet group to a control group receiving standard diabetes management.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Luo wu
• Email: luowubio@163.com
• Phone: 13687333270

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.