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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214235
• Other study ID #: KY20212189-C-1
• Status: Recruiting
• Start date: February 7, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: June 2022
• Source: Xijing Hospital
• Contact: Yafei Feng, Doctor
• Phone: 15829552527
• Email: fengyafei2005[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: February 29, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Spinal Diseases

Intervention

Drug:
• Hypoglycemic Drugs
Patients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before surgery
Primary	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.	at 3 months after surgery
Primary	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.	at 6 months after surgery
Primary	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.	at 1 year after surgery.
Primary	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.	before surgery
Primary	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.	at 3 months after surgery
Primary	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.	at 6 months after surgery
Primary	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.	at 1 year after surgery
Primary	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.	before surgery
Primary	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.	at 3 months after surgery
Primary	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.	at 6 months after surgery
Primary	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.	at 1 year after surgery
Secondary	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.	at 3 months after surgery
Secondary	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.	at 6 months after surgery
Secondary	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.	at 1 year after surgery
Secondary	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.	at 3 months after surgery
Secondary	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.	at 6 months after surgery
Secondary	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.	at 1 year after surgery