Clinical trial NCT05214235: A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients
Official title: A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Spinal Diseases
Keywords: Elective spinal surgery
Metformin
Sitagliptin
Prognosis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of diabetic patients requiring elective spinal surgery.

Brief summary: Diabetes mellitus is a group of metabolic diseases caused by multiple etiologies and characterized by chronic hyperglycemia. It seriously harms human health and has become a global public health challenge. Diabetes mellitus is present in 5% to 25% of patients undergoing spine surgery, and the prevalence has been increasing over the past decade. It is worth noting that spinal surgery for patients with diabetes has significant risks, mainly manifested in the significant increase of postoperative complications such as wound infection, delayed healing and wound hematoma, which seriously affect the long-term prognosis of patients' quality of life, spinal function and stability of internal fixation. Research shows that hypoglycemic drugs can not only control blood glucose level, but also affect the stability of nerve, bone and internal fixation, which is expected to improve the prognosis of spinal surgery in patients with diabetes. Metformin and sitagliptin are widely used hypoglycemic drugs. Studies have shown that metformin can increase bone mineral density in patients and have a protective effect on bones. Sitagliptin induces macrophage polarization of the M2 phenotype and reduces the impaired behavior of osteoblasts on titanium (TI) implants in a dose-dependent manner, thereby enhancing the bone regeneration required for successful orthopedic and dental implants in diabetic patients. However, the effects of these two drugs on the long-term prognosis of diabetic patients after spinal surgery, such as quality of life, spinal function and stability of internal fixation, have not been reported.

This investigation is a prospectie cohort study. The purpose of this study is to determine whether metformin and sitagliptin are associated with patient-reported outcomes and internal fixation stability at one year following elective spine surgery. Providers may use this information to help patients who need elective spinal surgery choose hypoglycemic drugs and to counsel patients with diabetes on expectations following spine surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective spinal surgery;
* Clinical diagnosis of diabetes (using the diagnostic criteria proposed by the WHO Expert Committee on Diabetes in 1999);
* Use metformin or sitagliptin;
* The age ranges from 18 to 90;
* Sign informed consent.

Exclusion Criteria:

* Acute traumatic injury;
* Patients with cerebral hemorrhage, cerebral infarction, Parkinson's disease, spinal cord transverse syndrome, spinal cord hemiere syndrome, Guillan-Barre syndrome and other neurological diseases affecting patients' somatosensory and motor;
* Combined with rheumatoid arthritis, ankylosing spondylitis and other rheumatoid arthritis;
* Patients with long-term use of glucocorticoids;
* complicated with malignant tumor;
* Pregnant women;
* Suffering from schizophrenia, bipolar disorder, hysteria and other mental diseases;
* The use of two or more than two mechanisms of hypoglycemic drugs;
* Do not sign informed consent.

Primary outcomes:
measure: Preoperative Quality of Life Score
timeFrame: before surgery
measure: Quality of Life Score at 3 Months after Surgery
timeFrame: at 3 months after surgery
measure: Quality of Life Score at 6 Months after Surgery
timeFrame: at 6 months after surgery
measure: Quality of Life Score at 1 Year after Surgery
timeFrame: at 1 year after surgery.
measure: Preoperative Oswestry Disability Index (ODI) or Neck Disability Index (NDI)
timeFrame: before surgery
measure: Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 3 Months after Surgery
timeFrame: at 3 months after surgery
measure: Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 6 Months after Surgery
timeFrame: at 6 months after surgery
measure: Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 1 Year after Surgery
timeFrame: at 1 year after surgery
measure: Preoperative Visual Analogue Scale (VAS)
timeFrame: before surgery
measure: Visual Analogue Scale (VAS) at 3 Months after Surgery
timeFrame: at 3 months after surgery
measure: Visual Analogue Scale (VAS) at 6 Months after Surgery
timeFrame: at 6 months after surgery
measure: Visual Analogue Scale (VAS) at 1 Year after Surgery
timeFrame: at 1 year after surgery
Secondary outcomes:
measure: Number of Participants with Spinal Fixation Loosening at 3 Months after Surgery
timeFrame: at 3 months after surgery
measure: Number of Participants with Spinal Fixation Loosening at 6 Months after Surgery
timeFrame: at 6 months after surgery
measure: Number of Participants with Spinal Fixation Loosening at 1 year after Surgery
timeFrame: at 1 year after surgery
measure: Number of Participants with Spinal Fusion at 3 Months after Surgery
timeFrame: at 3 months after surgery
measure: Number of Participants with Spinal Fusion at 6 Months after Surgery
timeFrame: at 6 months after surgery
measure: Number of Participants with Spinal Fusion at 1 Year after Surgery
timeFrame: at 1 year after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
state: Shaanxi
Study officials:
References: