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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

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

330

estimated

Study population

Type 2 diabetes

Key I/E criterion

HbA1c ≥7.5%

Primary endpoints

Bone metabolismBone mineral densityHbA1c

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06182852
Org study IDKY20231109-08

Timeline

Milestones

Study first posted2023-12-27actual
Last update posted2023-12-27actual
Study start2024-01-01estimated
Primary completion2024-12-31estimated
Study completion2025-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
2
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body fat

Time frame:3、6、9、12month

Total fat mass

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

HbA1c

Time frame:0、3、6、9、12month

descriptive, improvement

LOINC 4548-4

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

Bone metabolism

Time frame:3、6、9、12month

change from baseline, improvement

Primary/protocol endpoint

Bone mineral density

Time frame:6、12month

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.