Clinical trial for Type 2 Diabetes
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
ClinicalTrials.gov ID: NCT05439226
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Yichang, Hubei, China
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 to 75 years. 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.