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

Diabete Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182852
• Other study ID #: KY20231109-08
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Huiqin Li
• Phone: 18951670913
• Email: lihuiqin496[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metabolism
• Diabete Type 2
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical Univesity	Nanjing	Nanjing,

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone metabolism	Changes of bone metabolic indexes before and after treatment	3?6?9?12month
Primary	Bone mineral density	Changes of bone mineral density before and after treatment	6?12month
Primary	HbA1c	the glycosylated hemoglobin level of patients	0?3?6?9?12month
Secondary	Body fat	The changes of body fat mass after treatment	3?6?9?12month