Type 2 diabetes Mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. Body mass (BMI) >25 kg/m2; 3. A diagnosis of T2DM based on the criteria of WHO; with obesity or metabolic disorders; 4. With insulin secreting function: a fasting C-peptide by the oral glucose tolerance test >1 ng/mL and a ratio of peak to fasting value >2 ng/mL; 5. Willing and able to comply with the program's research process; 6. Be able to understand and sign the informed consent, if it is illiterate, willing to informed consent on the letter.
Exclusion criteria
Exclusion criteria: 1. T2DM duration over 15 years; 2. With drug or alcohol abuse history in 2 years before visiting; 3. WIth gastrointestinal surgery history. Except for appendectomy, cholecystectomy, liver biopsy and endoscopic surgery; 4. Planing to have surgery in Visit 1 to Visit 3, except for endoscopic exam; 5. Patients in pregnancy or breastfeeding during screening, or plan to pregnancy during one year follow-up; 6. Psychiatric disorders that may affect clinical research compliance, including dementia, active psychosis, severe depression, or attempted suicide; 7. Those who meet any of the following conditions: (1) With gastrointestinal inflammatory diseases, including severe refractory esophagitis, gastric ulcer, duodenal ulcer, or specific inflammation during the last 10 years, such as Crohn's disease or ulcerative colitis. (2) End-stage renal disease (ESRD); (3) Glutamate decarboxylase antibody (GADA), protein lysine phosphatase antibody (IA-2A) positive; (4) Low immune function, such as long-term oral steroid hormones history, cancer chemotherapy drugs history, or immunodeficiency diseases history; 8. Participate in any other clinical study (except for registration or research studies) within 30 days prior to visit 1 (screening visit) or within five trial drug half-lives (possibly longer), or during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index;Waist circumference;serum glucose;glycosylated hemoglobin;serum lipids;serum insulin;serum C-peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;heart rate; | — |
Countries
China
Contacts
Shanghai Sixth people's hospital