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

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called a GLP-1 receptor agonist affects bone health in patients with type 2 diabetes over one year. Researchers want to understand if this medication can improve bone metabolism, which is how the body builds and breaks down bone tissue. The trial is not yet recruiting participants, but when it starts, it will focus on adults aged 65 to 74 who have been diagnosed with diabetes and have certain blood sugar levels.

To participate, individuals will need to agree to follow the study rules and provide written consent. However, some people may not be eligible, including those who have recently used specific diabetes medications, had certain medical conditions like pancreatitis, or have undergone specific heart procedures. Participants in the study will likely have regular check-ups and tests to monitor their bone health and overall well-being throughout the year. This trial aims to provide valuable information that could help improve treatment options for people with diabetes and bone health issues.

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Eligibility criteria

• 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