Type 2 diabetes with obesity
Conditions
Interventions
Experimental group:After metabolic surgery, L1-4 or femoral neck or total hip bone mineral density Z value =-2.5 SD .The experimental group started to inject zoledronic acid (Migdal).It is from Novart
control group:After metabolic surgery,L1-4 or the femoral neck or total hip bone mineral density Z value =-2.5 SD.The control group began to give mock agents: dosage form: pre-perfusion injection. Spe
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The operation was performed according to the indications of metabolic surgery in the Chinese guidelines for the prevention and treatment of type 2 diabetes. 2. Aged 18 to 45 years without menopause when signing the Informed Consent Form (ICD); 3. lumbar spine 1-4 or femoral neck or total hip bone density Z value (measured value - average bone density of the same age) / standard deviation of bone density of the same age) <= - 2.5SD. 4. Willing and able to comply with the research process of the program; 5. Be able to understand and sign the study informed consent, if it is illiterate, willing to make a handprinting on the informed consent.
Exclusion criteria
Exclusion criteria: 1. history of cardiovascular or cerebrovascular diseases; 2. uncontrolled hypertension (SBP >= 160mmhg or DBP >= 100mmhg while screening); 3. history of unstable or rapidly progressive kidney; 4. active liver disease while screening; 5. history of diagnosed mental illness or immunocompromised; 6. any type of malignant tumor (whether cured or not); 7. osteoporosis caused by other reasons or drugs. 8. history of alcoholism or drug abuse; 9. Patients known to be allergic to bisphosphonates or allergic constitution; 10. Women of childbearing age are reluctant to use contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in lumbar spine bone mineral density (BMD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of clinical fractures;Neck of femoral, total hip BMD;Biochemical indicators of bone metabolism; | — |
Countries
China
Contacts
Public ContactJunfeng Han
Shanghai Sixth People's Hospital
Outcome results
None listed