Type 2 diabetes mellitus
Conditions
Interventions
experimental group:insulin and intestinal flora
Sponsors
Shantou Longhu People's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) The informed consent of the subjects was obtained before any trial related activities (including those for assessing the eligibility of the subjects), and the patients voluntarily participated in the trial, and the compliance was good; 2) Male or female aged 18-65 at the time of screening; 3) According to the diagnostic criteria of the American Diabetes Association (ADA) for type 2 diabetes mellitus (T2DM) in 2019; 4) The body weight should meet the following requirements (a or b): a) BMI >= 24.0 kg / m2; b) waist circumference > 80 cm for women and 85 cm for men. 5) The female subjects had no family planning during the trial period and took corresponding contraceptive measures.
Exclusion criteria
Exclusion criteria: 1) There were more than two ketoacidosis events or hyperosmolar hyperglycemia episodes in 6 months before screening; 2) According to the researchers' judgment, major hypoglycemia events or unintentional hypoglycemia occurred repeatedly before screening; 3) Patients with liver cirrhosis and various serious liver diseases (alanine aminotransferase or / and glutamic oxaloacetic transaminase exceeding 3 times of the upper limit of normal value), patients with renal dysfunction (serum creatinine exceeding the upper limit of normal value), kidney disease and other diseases requiring control of protein intake, etc; 4) Patients who received other hormone therapy in the past 3 months; 5) Those who are known to be allergic to insulin, orlistat, or any component, or have contraindications or intolerance; 6) Pregnant and lactating women; 7) Mental illness; drug abusers or alcohol and tobacco addicts; 8) Participants in clinical research of other new drugs in recent 3 months; 9) Patients with other weight loss drugs; 10) Patients with serious heart and brain diseases in recent three months; 11) HBsAg, HCV antibody, human immunodeficiency antibody and syphilis antibody were positive; 12) Because of the failure to comply with the requirements of the study protocol, the researchers considered that it was difficult for the patients to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight;Blood glucose control;homa-ir;Islet cell function;Changes of Intestinal Microecology; | — |
Secondary
| Measure | Time frame |
|---|---|
| FBG;2hPPG;HbA1c;FINS;2 hours postprandial insulin;Fasting C-peptide;??2hC? Postprandial 2hc peptide;routine blood test;hypoglycemia; | — |
Countries
China
Contacts
Public ContactHou Kaijian
Longhu People's Hospital
Outcome results
None listed