type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Tongji Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) male or female aged 50-80 (including 50 and 80) at the time of signing the informed consent; (2) patients with type 2 diabetes and non-diabetic controls who were confirmed to meet the diagnostic criteria for type 2 diabetes (1999) issued by the WHO at the time of screening; (3) the t-value of DXA bone density is greater than -2.5; (4) BMI 18.5 to 35.0 kg/m2; (5) do not need to rely on others for help in daily life; (6) 1 year before screening and during the follow-up of the project, anti-diabetic drugs and lifestyle control were applied to control their blood glucose except for TZDs and insulin; (7) agree to maintain the same diet and exercise habits throughout the study, and follow up in time according to the study requirements; (8) sign a written informed consent and abide by the study protocol.
Exclusion criteria
Exclusion criteria: (1) have a history of significant cardiovascular and cerebrovascular diseases, which is defined as: During the first 6 months of screening, subjects had a history of myocardial infarction, coronary angioplasty or bypass, valvular disease or valvular repair, clinically unstable arrhythmia, unstable angina, transient ischemic attack, and cerebrovascular accident; congestive heart failure classified as class III or IV by the New York heart association (NYHA); uncontrolled hypertension with antihypertensive drugs (at least 4 weeks) that has been applied at screening (systolic pressure > 160mmHg or diastolic pressure > 100mmHg at screening); a history of unstable or rapidly progressive kidney disease; in the active liver disease phase when screening; a clearly diagnosed history of mental illness; have a history of hemoglobinopathy (e.g., sickle cell anemia or thalassemia, iron granulocyte anemia); subjects with low immunity, such as those who have received organ transplantation or have been diagnosed with human immunodeficiency virus infection (such as HIV); any type of malignant tumor (whether cured or not); clinically diagnosed type 1 diabetes, diabetes caused by pancreatic damage or other special types of diabetes; (2) diseases or drug use that cause secondary osteoporosis; (3) Application of TZDs hypoglycemic drugs within 1 year before screening and during follow-up; (4) have a history of drug abuse; (5) patients usually drink 2 units of > every day or 14 units of > every week; One unit of alcohol is equivalent to 150 mL of wine or 350 mL of beer or 100mL of low-alcohol wine (17 degrees or less), 80mL (>17 degrees or 24 degrees or 50 mL of high-alcohol wine (>24 degrees).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractures of spine and hip; | — |
Secondary
| Measure | Time frame |
|---|---|
| all sites fractures; | — |
Countries
China
Contacts
Public ContactLige Song
Tongji Hospital, Tongji University School of Medicine
Outcome results
None listed