Type 2 Diabetes Intervention by Gut Microbiota-directed Diet -a Open Labelled RCT (T2D)

This is an interventional health services research trial for Type 2 Diabetes Read More

Inclusion Criteria:

• Newly diagnosed type 2 diabetes mellitus patients who have been diagnosed or screened for treatment without any hypoglycemic drugs;
• 6.5%≤HbA1c≤8.5%；
• FPG<10.0mmol/L;
• BMI≥24；

Exclusion Criteria:

• suspected other types of diabetes
• Moderate stroke occurred within one year;
• Frequent diarrhea or constipation in the past 3 months (more than 4 times / week);
• Acute complications occurred in the past 3 months, such as infection, ketosis and acidosis;
• Pregnant and lactating women (or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives);
• Drinking (1 weeks of drinking more than 5 times, on average 2 two Baijiu or half Jin of yellow wine or 5 bottles of beer above);
• Those who have received drug treatment for the following diseases in the past three months: cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other thyroid dysfunction;
• Gastrointestinal surgery (except appendicitis and hernia surgery);
• Antibiotics have been used in the past 3 months for 3 days or more;
• Physical methods, such as liposuction or gastrointestinal reconstruction, have been used to lose weight in the past 3 months;
• Physical disability, or inability to take care of themselves, recall and answer questions clearly due to other reasons;
• Anemia: hemoglobin < 10g / dl;
• Patients with severe liver diseases such as chronic hepatitis, persistent hepatitis and cirrhosis, and hepatitis B virus surface antigen (HBsAg) positive and abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase are 2.5 times the normal value).
• Other serious diseases, such as malignant tumors, serious mental diseases, serious infectious diseases, etc;
• Patients who are participating in other intervention studies;
• In the judgment of the study physician, there are any conditions that affect the study compliance, such as:Alcohol or drug abuse in the past 12 months; Serious adverse drug treatment compliance in the past 12 months; The residence is far away from the research center, or it is planned to move far away or travel frequently in the next year; The clinical diagnosis of dementia or the judgment of cognitive function by the research physician will affect the research compliance; Other medical, psychological or behavioral factors that affect the study compliance are judged by the study physician.