Type 2 Diabetes
Conditions
Interventions
intervention group:Probiotic pellets 2g/day
control group:Resistant dextrin 2g/day
Sponsors
Lianshui People's Hospital Affiliated to Kanda College, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Between the ages of 18 and 60; (2) The 1999 WHO diagnostic criteria for type 2 diabetes mellitus were used as the diagnostic criteria for type 2 diabetes mellitus in this study, and any one of the following had to be fulfilled: ? Randomized blood glucose =11.1 mmol/L; ? Fasting blood glucose = 7 mmol/L (126 mg/dl); ? 2-hour postprandial blood glucose =11.1 mmol/L (200 mg/dl); ? HbA1c=6.5%; (3) History of diabetes less than 5 years; (4) Patients with BMI =25kg/m2 (or waist circumference >90cm for men and >85cm for women); (5) Fasting C-peptide =1.1 µg/L,2h postprandial C-peptide =2.5 µg/L.
Exclusion criteria
Exclusion criteria: (1) Patients with type 1 diabetes mellitus, poorly controlled diabetes mellitus (HbA1c >8.5%), combined cardiac, cerebral, renal and peripheral vascular disease, severe retinopathy with clinical manifestations; (2) Pregnant or lactating women, or women with intent to become pregnant during the course of the study, who are hypersensitive to the test samples; (3) History of cardiac, hepatic, renal, pulmonary, gastrointestinal, pancreatic, thyroid, pituitary, and immune dysfunction disorders, psychiatric disorders, neoplasms, alcohol dependence, or substance abuse; (4) Those who had taken antibiotics or preparations containing prebiotics, probiotic preparations and live bacterial preparations in the last 3 months and intervention period, those who had taken vitamins, minerals, estrogens, progestins, corticosteroids, cholesterol-reducing and lipid-lowering medications, change in insulin injection medication or dosage, and change in oral hypoglycemic medication or dosage in the 3 weeks prior to the intervention and intervention period; (5) Those who did not take the subject as prescribed, fell below 90% of the test dose or experienced any gastrointestinal adverse effects, and those whose incomplete information affected the observations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood sugar;HbA1c;Diversity analysis of intestinal flora;Seven items of blood lipids;insulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function 15 items;kidney function;routine blood test;urine routine;fecal routine;C-peptide;TNF-a;Hs-CRP;IL-1;IL-6;lipocalin;immunoglobulin (IgA, IgG, IgM, IgD);Complement (C3, C4, CD4, CD8);Digestive Tract Tumor Indicators: CEA, CA199, AFP, CA125, CA724;Biochemical indices of intestinal barrier function: D-lactate, diamine oxidase, bacterial endotoxin; | — |
Countries
China
Contacts
Public ContactLihua Life
Lianshui People's Hospital Affiliated to Kanda College, Nanjing Medical University
Outcome results
None listed