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

Not yet recruiting

• Conditions: Bone Metabolism; Diabete Type 2

• Registration Number: NCT06182852
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Study Start: 2024-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Bone metabolism	3、6、9、12month	Changes of bone metabolic indexes before and after treatment

Secondary Outcome Measures

Name	Time	Method
Body fat	3、6、9、12month	The changes of body fat mass after treatment

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical Univesity; 🇨🇳 Nanjing, Nanjing,, China