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

NCT06182852 | Unknown DMC

• 1 other identifier: KY20231109-08
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabete Type 2; Bone Metabolism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Body fat

  3、6、9、12month

Study Arms (1)

glucagon-like peptide-1receptor agonists

Once a week, hypodermic injection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosed patients with diabetes
• HbA1c≥7.5%；
• Willing to sign a written informed consent form and abide by the research plan

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, Nanjing,, 210006, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Huiqin Li

CONTACT

18951670913; lihuiqin496@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-11

Locations

CN (1)