Type 2 Diabetes Mellitus
Conditions
Interventions
Lifestyle intermittent compound intervention group:Lifestyle intermittent compound intervention
Simple diet intermittent intervention group:Simple diet intermittent intervention
Control group:Lifestyle recommendations
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 64 years old; 2. Type 2 diabetes mellitus; 3. Treated with metformin alone or metformin combined with dipeptidyl peptidase-4 inhibitor for >= 8 weeks; 4. Glycosylated hemoglobin (HbA1c) >= 7% and = 24.0; 6. Estimated glomerular filtration rate (eGFR) >= 60 and alanine aminotransferase (ALT) = 3 times a year); 8. No acute diabetic complications.
Exclusion criteria
Exclusion criteria: 1. Other types of diabetes besides type 2 diabetes; 2. Pregnant or planned pregnant or lactating women (premenopausal women must obtain negative pregnancy test results when entering the study and use medically approved contraceptives); 3. Uncorrected acute diabetic complications [diabetic ketoacidosis (DKA), hyperosmolar hyperglycemia (HHS), lactic acidosis]; 4. Positive result in exercise treadmill test; 5.eGFR=120U/L with definite diagnosis of coronary heart disease, chronic kidney disease, and other diseases that need to start other second-line treatment drugs according to the guidelines; 6. History of renal transplantation; 7. NYHA II-VI; 8. Stroke and myocardial infarction in the past 12 months; 9. History of serious mental disorders; 10. Hemoglobinopathy or uncorrected severe anemia; 11. Unexplained hypoglycemia with disturbance of consciousness in the past 6 months; 12. No smartphone or unable to use mobile phone software; 13. Possible failure to comply with protocol requirements: including communication barriers, uncooperative attitude, failure to follow up and failure to complete the study; 14. Situations that may endanger the safety of patients or fail to successfully participate in the study: including medical, psychological, geographical factors, etc; 15. Those who participated in the clinical trial within the first 8 weeks of randomization, failed to complete the research follow-up for half a year, and required surgery within half a year, which needed to be replaced with insulin treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Amplitude of Glycemic Excursions;Time In Range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Exercise self-efficacy;Exercise self-management ability;Exercise behavior;HbA1c;Blood pressure;Body weight;body fat rate; | — |
Countries
China
Contacts
Public ContactAng Li
Peking University First Hospital
Outcome results
None listed