Type 2 Diabetes
Conditions
Interventions
Experimental group:Diabesso(p.o.)+lifestyle guidance+ hypoglycemic agents(po.)
control group:lifestyle guidance+ hypoglycemic agents(p.o.)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be selected, the following four conditions must be satisfied: 1. Comply with the diagnostic criteria for type 2 diabetes in the 1999 WHO Diabetes Diagnosis and Classification Standard:Clear clinical record of fasting blood glucose (FPG) >= 7mmol /L or 75g OGTT (2h) >= 11.1mmol /L; T2DM of duration > 1 year (diagnosis based on the 1999 WHO Diabetes Diagnosis and Classification Standard in China); not use insulin rightnow; 2. Body mass index: 18.5 kg/m2 <= BMI <= 35kg/m2; 3. Men and women aged 18-75 years; 4. Volunteer to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Those with any of the following conditions should be excluded : 1. Acute cardiovascular and cerebrovascular events or myocardial infarction within previous 6 months; 2. Laboratory inspection: Liver function: AST and / or ALT >= 2.5xULN; Renal function: Cr>1.2xULN; 3. People with severe gastrointestinal diseases, such as active peptic ulcer, intestinal obstruction, etc;have a history of changes in the normal structure of the gastrointestinal tract; 4. Hypertensive patients with poor blood pressure control(blood pressure SBP>=160mmHg and / or DBP>=100mmHg); 5. Those with severe blood system diseases; 6. Combine other endocrine system diseases (such as hyperthyroidism or hypercortisolism); 7. Patients with stress or secondary blood glucose elevation (such as taking glucocorticoids); 8. Pregnant or lactating women,and women who are not willing to contraception during pregnancy or study; 9. Drug or substance abusers; 10. People who may be allergic to the test drug; 11. Those who have participated in other drug trials during the past 3 months; 12. Those who cannot cooperate for mental illness or other illness; 13. Other conditions,if the patients are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin a1c;plasma glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma insulin;hs-CRP;blood lipid;gut microbiota;Short chain fatty acid; | — |
Countries
China
Contacts
Public ContactKang Junren
Department of Clinical Nutrition, Peking Union Medical College Hospital
Outcome results
None listed