First-onset type 2 diabetes
Conditions
Interventions
control group:placebo
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed T2D patients according to the 1999 World Health Organization criteria (FBG 7 mmol/l or greater and / or 2-h OGTT 11.1 mmol/l or greater) who had not previously received pharmacological treatment; 2. 6.5% <= HbA1c <= 10%; 7 <= FBG <= 13.0 mmol/L; 3. Age 30 - 70 years old; 4. Body mass index (BMI): 24.0 <= BMI <= 30.0 kg·m-2; 5. Individuals who have not participated in any clinical trials within 3 months before being selected; 6. No serious heart, liver, or kidney diseases; 7. Able to keep taking granules for 3 months.
Exclusion criteria
Exclusion criteria: 1 Impaired liver function defined as AST / ALT excessed the upper limit of the normal range by 2.5 times; Renal insufficiency defined as serum creatinine > 132µmol·L-1 or estimated glomerular filtration rate (eGFR) = III; 3. Diabetes caused by type 1 diabetes, monogenic diabetes, pancreatic injury or other secondary diabetes (such as Cushings syndrome, thyroid abnormalities and acromegaly); 4. Treatment with anti-diabetic drugs including oral anti-diabetic drugs, GLP-1 agonists or insulin; 5. A history of acute diabetic complications within 3 months, including diabetic ketoacidosis or hyperosmolar hyperglycemia nonketotic coma; 6. Have used antibiotics, steroid hormones, cytokines that can stimulate the body's immune system, methotrexate and other immunosuppressants in the past three months; used topical antibiotics (such as mouthwash) in the past 7 days; 7. Taking weight-loss drugs; corticosteroids administered by oral, intramuscular, intravenous, parenteral or intraarticular within the past 3 months; 8. Gastrointestinal diseases which can cause accurate chronic diarrhea or severe constipation; 9. Serious diseases such as tumor, immune system, blood system and other diseases in the past 5 years; 10. The history of bowel resection or other gastrointestinal surgery (such as cholecystectomy) in the past 1 year, or other history of parenteral surgery in the past 6 months; 11. History of substance addiction and alcohol abuse; 12. Pregnancy (HCG-positive urine in women of reproductive period), breastfeeding; 13. From the researcher's point of view, any factors that may interfere with the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal permeability;Gut microbial profiling; | — |
Countries
China
Contacts
Public ContactLu Hao
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed