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New treatment option for Type 2 Diabetes Mellitus
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 (Version 3.0)
ClinicalTrials.gov ID: NCT07083336
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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;
See the full eligibility criteria
- 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.
- 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;
- Respiratory system conditions such as pulmonary embolism, cor pulmonale;
- Musculoskeletal system conditions such as arterial rupture, myeloma;
- Immune system conditions such as Behçet's disease, lupus erythematosus;
- Conditions such as chondrosarcoma, liposarcoma, brucellosis, leukemia;
- History of malignant tumor within the past 5 years, or currently under evaluation for potential malignancy;
- History of unstable or treatment-requiring proliferative retinopathy or macular edema within the past 6 months;
- History of diabetic ketoacidosis or hyperosmolar nonketotic diabetic coma within the past 6 months;
- Currently suffering from lower extremity arteriosclerotic occlusive disease; History of severe infection or severe trauma within the past 1 month;
- History of ≥2 severe hypoglycemic episodes within the past year;
- Currently suffering from clinically significant urinary tract/genital infection, or a history of complicated urinary tract infections, or recurrent urinary tract infections within the past 6 months;
- Currently suffering from uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening/baseline, or systolic blood pressure ≤90 mmHg and/or diastolic...
- Currently suffering from uncontrolled thyroid dysfunction;
- History of other severe endocrine diseases, such as multiple endocrine neoplasia;
- History of severe hepatic or renal disease;
- Suspected or confirmed history of alcohol or drug abuse;
- Blood donation or blood loss ≥400 mL within the past 3 months;
- Presence of severe psychiatric disorders or language barriers, unwillingness or inability to fully understand and cooperate;
- Pregnant or breastfeeding women;
- Any other conditions deemed unsuitable for trial participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Yichang, Hubei, China
- Changsha, Hunan, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yichang, Hubei, China; Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.