An Observational Clinical Study on the Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Bone metabolism
研究概览
简要总结
Through an one-year follow-up, to explore the effect of GLP-1 receptor agonist on bone metabolism in patients with diabetes.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed patients with diabetes
- •HbA1c≥7.5%；
- •Willing to sign a written informed consent form and abide by the research plan
排除标准
- •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
结局指标
主要结局
Bone metabolism
时间窗: 3、6、9、12month
Changes of bone metabolic indexes before and after treatment
Bone mineral density
时间窗: 6、12month
Changes of bone mineral density before and after treatment
HbA1c
时间窗: 0、3、6、9、12month
the glycosylated hemoglobin level of patients
次要结局
- Body fat(3、6、9、12month)