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

NCT05214235 | Unknown FDA Drug

• 1 other identifier: KY20212189-C-1
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Spinal Diseases

Keywords

Elective spinal surgery; Metformin; Sitagliptin; Prognosis

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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.

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Number of Participants with Spinal Fixation Loosening 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

• Number of Participants with Spinal Fusion 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

Study Arms (2)

Metformin

Patients who use metformin to control blood sugar level.

Drug: Hypoglycemic Drugs

Sitagliptin

Patients who use sitagliptin to control blood sugar level.

Drug: Hypoglycemic Drugs

Interventions

Hypoglycemic Drugs DRUG

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

Metformin; Sitagliptin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A population of diabetic patients requiring elective spinal surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Spinal Diseases

Interventions

Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Yafei Feng, Doctor

CONTACT

15829552527; fengyafei2005@163.com

Kaili Hao, Master

CONTACT

17683914056; haokaili2020@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 28, 2022
• Study Start: February 7, 2022
• Primary Completion: February 7, 2024
• Study Completion: February 29, 2024
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

CN (1)