Clinical trial NCT06182852: The Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus
Official title: An Observational Clinical Study on the Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabete Type 2
Bone Metabolism
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Diagnosed patients with diabetes
2. HbA1c≥7.5%

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone metabolism
timeFrame: 3、6、9、12month
measure: Bone mineral density
timeFrame: 6、12month
measure: HbA1c
timeFrame: 0、3、6、9、12month
Secondary outcomes:
measure: Body fat
timeFrame: 3、6、9、12month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical Univesity
state: Nanjing,
Study officials:
References: