type 2 diabetes
Conditions
Interventions
groupA:In addition to their regular diet, consumed 200ml of regular black tea before and after each of the three daily meals.
groupB:In addition to their regular diet, consumed 200ml of Yingjiu Yi Tang Tea before and after each of the three daily meals.
Sponsors
Nantong University Affiliated Dongtai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with type 2 diabetes mellitus (according to WHO criteria); (2) Meeting one of the following criteria: 1) Newly diagnosed and not having taken any glucose-lowering medications; 2) Undergoing lifestyle interventions only; 3) Long-term use of metformin or thiazolidinediones alone for glycemic control; 4) Using only basal insulin (glargine or degludec) for glycemic control with a stable dose for the past week; (3) Glycated hemoglobin (HbA1c) level of 7.0–10.0%; (4) Age between 18 and 70 years; (5) Voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Women who are pregnant or breastfeeding, or women of childbearing potential who are unwilling or unable to use adequate contraception; (2) History of alcohol abuse (defined as drinking alcohol more than 5 times per week, with an average consumption per occasion of =100 ml of liquor, or =250 ml of rice wine, or =5 bottles of beer) or smoking; (3) History of severe psychiatric disorders within the past 6 months; (4) Previous gastrointestinal surgery, except for appendectomy or hernia repair; (5) Patients with chronic or persistent hepatitis, severe liver diseases such as cirrhosis, or those who are hepatitis B surface antigen (HBsAg) positive with abnormal liver function (serum ALT and AST levels 2.5 times the upper limit of normal); (6) Patients with Cushing's syndrome, pituitary dysfunction, or other endocrine system diseases; (7) Factors that may interfere with participation in the study, such as unstable medical conditions, including hypertension and cardiovascular diseases: i. Malignant hypertension (blood pressure >180/110 mmHg, systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg); or uncontrolled hypertension; ii. Myocardial infarction, other acute cardiac events requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure; (8) Patients with infectious diseases such as tuberculosis and AIDS; (9) Anemia: hemoglobin <10 g/dl; (10) Severe renal insufficiency: GFR <=30 ml/min/1.73 m²; (11) History of ketosis, ketoacidosis within the past month, or uncontrolled infections; (12) Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glucose;Glycated Albumin;Time in Range;liver function tests; | — |
Secondary
| Measure | Time frame |
|---|---|
| renal function;blood lipids;insulin;C-peptide;7-point glucose profile;Oral Glucose Tolerance Test;Bile acid profile;Glucagon-Like Peptide-1;Gastric Emptying Rate;Glycosuria;Complete Blood Count; | — |
Countries
China
Contacts
Public ContactHongbin Zhu
Nantong University Affiliated Dongtai Hospital
Outcome results
None listed