An observational study in Diabetes Mellitus and Spinal Diseases, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by Xijing Hospital · Observational
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.
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's planned enrollment of 124 is above the median of 108 across 87 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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A population of diabetic patients requiring elective spinal surgery.
Exclusion Criteria:
Patients who use metformin to control blood sugar level.
Drug: Hypoglycemic Drugs
Patients who use sitagliptin to control blood sugar level.
Drug: Hypoglycemic Drugs
Patients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took.
Preoperative Quality of Life Score
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.
Time frame: before surgery
Quality of Life Score 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.
Time frame: at 3 months after surgery
Quality of Life Score 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.
Time frame: at 6 months after surgery
Quality of Life Score 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.
Time frame: at 1 year after surgery.
Preoperative Oswestry Disability Index (ODI) or Neck Disability Index (NDI)
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.
Time frame: before surgery
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) 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.
Time frame: at 3 months after surgery
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) 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.
Time frame: at 6 months after surgery
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) 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.
Time frame: at 1 year after surgery
Preoperative Visual Analogue Scale (VAS)
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.
Time frame: before surgery
Visual Analogue Scale (VAS) 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.
Time frame: at 3 months after surgery
Visual Analogue Scale (VAS) 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.
Time frame: at 6 months after surgery
Visual Analogue Scale (VAS) 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.
Time frame: at 1 year after surgery
Number of Participants with Spinal Fixation Loosening at 3 Months after Surgery
Spinal fixation loosening is evaluated by anteroposterior and lateral X-ray. The evaluation criteria were: a gap of more than 1mm around the screw is considered as spinal fixation loosening.
Time frame: at 3 months after surgery
Number of Participants with Spinal Fixation Loosening at 6 Months after Surgery
Spinal fixation loosening is evaluated by anteroposterior and lateral X-ray. The evaluation criteria were: a gap of more than 1mm around the screw is considered as spinal fixation loosening.
Time frame: at 6 months after surgery
Number of Participants with Spinal Fixation Loosening at 1 year after Surgery
Spinal fixation loosening is evaluated by CT scan. The evaluation criteria were: a gap of more than 1mm around the screw is considered as spinal fixation loosening.
Time frame: at 1 year after surgery
Number of Participants with Spinal Fusion at 3 Months after Surgery
Dynamic X-ray is used to evaluate the spinal fusion. The criteria of spinal fusion:(1) there is continuous bone trabeculae passing between vertebrae with increased density; (2) The translation on the X-ray dynamic position film is less than 3mm, and the angular motion is less than 5°; (3) The bone connected to the vertebral body is constantly growing; (4) The relative displacement between adjacent spinous processes of fusion segment measured by X-ray dynamic position film is less than or equal to 2 mm.
Time frame: at 3 months after surgery
Number of Participants with Spinal Fusion at 6 Months after Surgery
Dynamic X-ray is used to evaluate the spinal fusion. The criteria of spinal fusion:(1) there is continuous bone trabeculae passing between vertebrae with increased density; (2) The translation on the X-ray dynamic position film is less than 3mm, and the angular motion is less than 5°; (3) The bone connected to the vertebral body is constantly growing; (4) The relative displacement between adjacent spinous processes of fusion segment measured by X-ray dynamic position film is less than or equal to 2 mm.
Time frame: at 6 months after surgery
Number of Participants with Spinal Fusion at 1 Year after Surgery
Dynamic X-ray is used to evaluate the spinal fusion. The criteria of spinal fusion:(1) there is continuous bone trabeculae passing between vertebrae with increased density; (2) The translation on the X-ray dynamic position film is less than 3mm, and the angular motion is less than 5°; (3) The bone connected to the vertebral body is constantly growing; (4) The relative displacement between adjacent spinous processes of fusion segment measured by X-ray dynamic position film is less than or equal to 2 mm.
Time frame: at 1 year after surgery
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Xijing Hospital