Diabetes MellitusNCT05214235
A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients
An observational study of Diabetes Mellitus and Spinal Diseases, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Spinal Diseases
- What is being tested?
- Hypoglycemic Drugs
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A population of diabetic patients requiring elective spinal surgery.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi'an, Shaanxi, 710032
Yafei Feng, Doctor, 15829552527, fengyafei2005@163.com
About this study
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
- Being tested
- Hypoglycemic Drugs
- Keywords
- Elective spinal surgery, Metformin, Sitagliptin, Prognosis
- Medical subject headings
- Diabetes Mellitus, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglycemic DrugsDrug
Patients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Patients who use metformin to control blood sugar level. Receives: Drug: Hypoglycemic Drugs | |
| Sitagliptin | Patients who use sitagliptin to control blood sugar level. Receives: Drug: Hypoglycemic Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 1 year after surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start7 Feb 2022
- Primary completion7 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FengYafei, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214235
- Sponsor's protocol ID
- KY20212189-C-1
- Status last verified
- Jun 2022
- First submitted
- 30 Dec 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients
- ClinicalTrials.gov ID
- NCT05214235
- Acronym / sponsor ID
- KY20212189-C-1
- Conditions
- Diabetes Mellitus, Spinal Diseases
- Keywords
- Elective spinal surgery, Metformin, Sitagliptin, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 7 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | – | Drug: Hypoglycemic DrugsPatients who use metformin to control blood sugar level. |
| Sitagliptin | – | Drug: Hypoglycemic DrugsPatients who use sitagliptin to control blood sugar level. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A population of diabetic patients requiring elective spinal surgery.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglycemic DrugsPatients were divided into metformin group and sitagliptin group according to the type of hypoglycemic drugs they took. | Drug | Metformin, Sitagliptin |
Primary outcome
Preoperative Quality of Life Score
Time frame: 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
Time frame: 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 6 Months after Surgery
Time frame: 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.
Quality of Life Score at 1 Year after Surgery
Time frame: 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)
Time frame: 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
Time frame: 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.
Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 6 Months after Surgery
Time frame: 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
Time frame: 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.
Preoperative Visual Analogue Scale (VAS)
Time frame: 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
Time frame: 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.
Visual Analogue Scale (VAS) at 6 Months after Surgery
Time frame: 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
Time frame: 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.
6 secondary outcomes
Number of Participants with Spinal Fixation Loosening at 3 Months after Surgery
Time frame: at 3 months after surgery
Number of Participants with Spinal Fixation Loosening at 6 Months after Surgery
Time frame: at 6 months after surgery
Number of Participants with Spinal Fixation Loosening at 1 year after Surgery
Time frame: at 1 year after surgery
Number of Participants with Spinal Fusion at 3 Months after Surgery
Time frame: at 3 months after surgery
Number of Participants with Spinal Fusion at 6 Months after Surgery
Time frame: at 6 months after surgery
Number of Participants with Spinal Fusion at 1 Year after Surgery
Time frame: at 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Spinal Diseases, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yafei Feng, Doctor (15829552527, fengyafei2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Quality of Life Score (time frame: before surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.