type 2 diabetes
Conditions
Interventions
Test group:Compound lactobacillus powder ZC-SUGII, washed with warm water below 40C, twice a day, one piece each time, for 90 days
control group:Compound lactobacillus powder ZC-SUGII simulative agent, washed with warm water below 40C for consumption, twice a day, one piece each time, for 90 days
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meet the ADA type 2 diabetes diagnostic criteria in 2022; 2. Newly diagnosed or previously diagnosed medical history less than 5 years, without receiving hypoglycemic drug treatment; 3. Age range of 18-60 years old (including boundary values), gender not limited; 4. 6.5% = HbA1c = 8.0%; 5. Body mass index>24.0 and = 28.0kg/m^2; 6. The subjects are informed, voluntarily sign the informed consent form, and agree to complete all visits, related examinations, and treatments in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Merge severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction (liver function alanine aminotransferase, aspartate aminotransferase exceeding 1.5 times the upper limit of normal reference value, or SCr exceeding 1.2 times the upper limit of normal reference value), and other malignant diseases; 2. Pregnant and lactating women; 3. Individuals with allergic constitution or allergies to trial products or ingredients; 4. Acute complications of diabetes occurred within 3 months, including diabetes ketoacidosis, hypertonic hyperglycemic non ketotic coma; 5. Have taken weight control medication (including weight-loss pills) within the past 3 months; Oral, intramuscular, intravenous or intra-articular injection of glucocorticoids; 6. History of malignant tumors (excluding local basal cell carcinoma) within the past five years, regardless of recurrence or metastasis; 7. History of drug and alcohol abuse; 8. Have participated in other population intervention studies within the past 3 months or will receive treatment from other non study groups midway; 9. Those who have a habit of consuming probiotics; 10. Other researchers consider it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of HbA1c from baseline after 90 days of trial ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of blood glucose (fasting blood glucose, plasma uveose level 2 h after standard meal) after 30, 60 and 90 days compared with baseline ;Changes of insulin resistance index (HOMA-IR) and islet beta cell function index (HOMA-ß) levels after 30, 60 and 90 days of trial ;Changes of insulin and C-peptide levels compared with baseline after 30, 60 and 90 days ;Serum triglycerides (TG), TC, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein A1, apolipoprotein B, apolipoprotein E ;Changes in body mass index (BMI) from baseline after 30, 60, and 90 days of trial ;Changes in Body Weight from Baseline after 30, 60 and 90 Days of Trial Feeding ;Compliance rate of HbA1c control after 90 days ( 1.04 mmol / L, female > 1.30 mmol / L) ;Control rate of BMI (BMI < 24.0kg / m2) after 30, 60 and 90 days of trial ; | — |
Countries
China
Contacts
Public ContactChao Zheng
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed