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

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

This study tests if a special Chinese diet can help people with type 2 diabetes and liver fat problems lower their liver fat and improve their blood sugar levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: State Key Laboratory of Subhealth Intervention Technology (Academic / other)
• Locations: 3 sites (Yichang, Hubei and 2 other locations)
• Trial ID: NCT05439226 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of type 2 diabetes and NAFLD, who are stable on diabetes medications.

Not a fit: Patients with other liver diseases, significant food allergies, or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve metabolic health and liver fat levels in patients with type 2 diabetes and NAFLD.

How similar studies have performed: Previous studies have shown positive outcomes with dietary interventions for diabetes management, suggesting potential success for this novel approach.

Eligibility criteria

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 this trial is running

Yichang, Hubei and 2 other locations

• 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

Conditions Type 2 Diabetes; Type 2 Diabetes with NAFLD; CMNT diet