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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Metabolism; Diabete Type 2

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 Type: Observational
• Enrollment (Estimated): 330

Contacts and Locations

• Study Contact: Name: Huiqin Li; Phone Number: 18951670913; Email: lihuiqin496@126.com

Study Locations

• China
  • Nanjing,
    • Nanjing, Nanjing,, China, 210006
      • Nanjing First Hospital, Nanjing Medical Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Diagnosed patients with diabetes
2. HbA1c≥7.5%

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
glucagon-like peptide-1receptor agonists; Once a week, hypodermic injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone metabolism	Changes of bone metabolic indexes before and after treatment	3、6、9、12month
Bone mineral density	Changes of bone mineral density before and after treatment	6、12month
HbA1c	the glycosylated hemoglobin level of patients	0、3、6、9、12month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat	The changes of body fat mass after treatment	3、6、9、12month

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Estimated): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KY20231109-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No