Bone Metabolism, Diabete Type 2
Conditions
Brief summary
Through an one-year follow-up, to explore the effect of GLP-1 receptor agonist on bone metabolism in patients with diabetes.
Detailed description
This study is a single-center observational study. After the patients were enrolled according to the standard of admission and exclusion, on the basis of the original scheme, GLP-1 receptor agonists were added and followed up for one year. The indexes of bone metabolism and body fat were measured at several time points (3 months, 6 months, 9 months and 12 months after treatment). Bone mineral density (BMD) was measured at several time points (6 months and 12 months after treatment) to explore the effect of GLP-1 receptor agonists on bone metabolism in patients with diabetes.
Interventions
None listed
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed patients with diabetes 2. HbA1c≥7.5%； 3. Willing to sign a written informed consent form and abide by the research plan
Exclusion criteria
1. Any of the following drugs or treatments were used within one month before screening: treated with GLP-1RA, GLP-1 analogues, DPP-4 inhibitors, or any other enterotropic insulin analogue 2. Long-term intravenous, oral and intra-articular administration of corticosteroids within 2 months before screening (more than 7 days in a row) 3. Use of weight control drugs or surgery that can lead to weight instability within the first 2 months of screening, or are currently in the weight loss plan and are not in the maintenance stage 4. History of acute and chronic pancreatitis; history of myeloid C cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history 5. There is a clinically significant abnormal gastric emptying. 6. Screening of any organ system tumors that have been treated or untreated within the previous 5 years 7. Underwent coronary angioplasty, coronary stent implantation and coronary artery bypass surgery within 6 months before selection, resulting in negligent compensatory heart failure (New York Heart Association NYHA classification III and IV), stroke or transient ischemic attack, unstable angina pectoris, myocardial infarction, persistent and clinically significant arrhythmias. 8. Acute metabolic complications occurred within 6 months before screening. （9）Before screening, any laboratory test index meets the following criteria: glutamic pyruvic transaminase \> 2.5 times or aspartate oxaloacetic transaminase \> 2.5 times; eGFR \< 45ml \< 45ml hand minmax 1.73m2; fasting triglyceride \> 5.64mmol/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone metabolism | 3、6、9、12month | Changes of bone metabolic indexes before and after treatment |
| Bone mineral density | 6、12month | Changes of bone mineral density before and after treatment |
| HbA1c | 0、3、6、9、12month | the glycosylated hemoglobin level of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat | 3、6、9、12month | The changes of body fat mass after treatment |
Countries
China
Contacts
Primary ContactHuiqin Li
Outcome results
None listed