type 2 diabetes
Conditions
Interventions
group A:Group A first underwent a 14-day intervention with regular diet + mineral water, followed by a 7-day wash-out period, and subsequently switched to a 14-day intervention with regular diet + Ba
group B:Group B first underwent a 14-day intervention with regular diet + Ba Shan, followed by a 7-day wash-out period, and subsequently switched to a 14-day intervention with regular diet + mineral w
Sponsors
Nantong University Affiliated Dongtai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosed with Type 2 diabetes mellitus; (2) Glycemic control managed with diet and exercise alone for at least 3 months or longer, or stable use of basal insulin for glucose lowering for 3 months or longer; (3) Fasting blood glucose >7.0 mmol/L, 2-hour postprandial blood glucose >11.1 mmol/L, and glycated hemoglobin (HbA1c) level between 7.0% and 8.5%; (4) Aged 18–60 years; (5) Voluntarily signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women, or women planning pregnancy who are unwilling or not taking adequate contraceptive measures; (2) History of alcohol abuse (drinking more than 5 times per week, with an average consumption per occasion of 2 liang of liquor, or half a jin of rice wine, or 5 bottles of beer or more) or smoking; (3) Severe mental disorders diagnosed within the past 6 months; (4) Previous gastrointestinal surgery, except for appendectomy and 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 accompanied by abnormal liver function (serum ALT and AST levels 2.5 times above the normal range); (6) Patients with Cushing's syndrome, pituitary dysfunction, or other endocrine system disorders; (7) Factors that may interfere with participation in the study, such as unstable medical conditions, including hypertension, cardiovascular diseases, etc. i. Malignant hypertension (blood pressure >180/110 mmHg, systolic pressure >180 mmHg or diastolic pressure >110 mmHg); uncontrolled or unstable blood pressure; 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 ketoacidosis, diabetic ketoacidosis, or uncontrolled infection within the past month; (12) The investigator deems the individual unsuitable for participation in this clinical trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose;postprandial blood glucose;Glucagon-Like Peptide-1;Complete Blood Count;liver function tests; renal function;blood lipids;insulin;C-peptide;Oral Glucose Tolerance Test;Bile acid profile;Gastric Emptying Rate;1,5-Anhydro-D-glucitol;insulin; | — |
Countries
China
Contacts
Public ContactShenghong Yao
Nantong University Affiliated Dongtai Hospital
Outcome results
None listed