A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Preoperative Visual Analogue Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Metformin
Patients who use metformin to control blood sugar level.
干预措施: Hypoglycemic Drugs (Drug)
Sitagliptin
Patients who use sitagliptin to control blood sugar level.
干预措施: Hypoglycemic Drugs (Drug)
结局指标
主要结局
Preoperative Visual Analogue Scale (VAS)
时间窗: before surgery
The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable.
Visual Analogue Scale (VAS) at 3 Months after Surgery
时间窗: at 3 months after surgery
The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable.
Preoperative Quality of Life Score
时间窗: before surgery
Preoperative quality of life score will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition.
Quality of Life Score at 3 Months after Surgery
时间窗: at 3 months after surgery
Quality of life score at 3 months after surgery will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition.
Quality of Life Score at 1 Year after Surgery
时间窗: at 1 year after surgery.
Quality of life score at 1 year after surgery will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition.
Preoperative Oswestry Disability Index (ODI) or Neck Disability Index (NDI)
时间窗: before surgery
The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability.
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 3 Months after Surgery
时间窗: at 3 months after surgery
The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability.
Visual Analogue Scale (VAS) at 6 Months after Surgery
时间窗: at 6 months after surgery
The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable.
Visual Analogue Scale (VAS) at 1 Year after Surgery
时间窗: at 1 year after surgery
The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable.
Quality of Life Score at 6 Months after Surgery
时间窗: at 6 months after surgery
Quality of life score at 6 months after surgery will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition.
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 6 Months after Surgery
时间窗: at 6 months after surgery
The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability.
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 1 Year after Surgery
时间窗: at 1 year after surgery
The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability.
次要结局
- Number of Participants with Spinal Fixation Loosening at 3 Months after Surgery(at 3 months after surgery)
- Number of Participants with Spinal Fusion at 6 Months after Surgery(at 6 months after surgery)
- Number of Participants with Spinal Fusion at 1 Year after Surgery(at 1 year after surgery)
- Number of Participants with Spinal Fusion at 3 Months after Surgery(at 3 months after surgery)
- Number of Participants with Spinal Fixation Loosening at 6 Months after Surgery(at 6 months after surgery)
- Number of Participants with Spinal Fixation Loosening at 1 year after Surgery(at 1 year after surgery)
研究者
FengYafei
Associate professor
Xijing Hospital