Status:
UNKNOWN
The Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Diabete Type 2
Bone Metabolism
Eligibility:
All Genders
18+ years
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 w...
Eligibility Criteria
Inclusion
- Diagnosed patients with diabetes
- HbA1c≥7.5%；
- Willing to sign a written informed consent form and abide by the research plan
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06182852
Start Date
January 1 2024
End Date
December 31 2025
Last Update
December 27 2023
Active Locations (1)
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1
Nanjing First Hospital, Nanjing Medical Univesity
Nanjing, Nanjing,, China, 210006