A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-07

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Spinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metformin

Patients who use metformin to control blood sugar level.

Hypoglycemic Drugs

Intervention Type DRUG

Patients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took.

Sitagliptin

Patients who use sitagliptin to control blood sugar level.

Hypoglycemic Drugs

Intervention Type DRUG

Patients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took.

Interventions

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Hypoglycemic Drugs

Patients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No