The Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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Through an one-year follow-up, to explore the effect of GLP-1 receptor agonist on bone metabolism in patients with diabetes.

Detailed Description
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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.

Official Title
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An Observational Clinical Study on the Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus

Conditions
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Diabete Type 2, Bone Metabolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed patients with diabetes HbA1c≥7.5%； Willing to sign a written informed consent form and abide by the research plan Exclusion Criteria: 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 Long-term intravenous, oral and intra-articular administration of corticosteroids within 2 months before screening (more than 7 days in a row) 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 History of acute and chronic pancreatitis; history of myeloid C cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history There is a clinically significant abnormal gastric emptying. Screening of any organ system tumors that have been treated or untreated within the previous 5 years 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glucagon-like peptide-1receptor agonists<br>Once a week, hypodermic injection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone metabolism | Changes of bone metabolic indexes before and after treatment | 3、6、9、12month | 
| Bone mineral density | Changes of bone mineral density before and after treatment | 6、12month | 
| HbA1c | the glycosylated hemoglobin level of patients | 0、3、6、9、12month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat | The changes of body fat mass after treatment | 3、6、9、12month |