Diabetes and Glycosylation in Cervical Spondylosis

Diabetes Clinical Trial

Official title:

The Effects of Diabetes and Glycosylation Profile on Outcomes in the Surgical Treatment of Cervical Spondylosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02758899
• Other study ID #: 201309048
• Status: Terminated
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the relevant significance of diabetes on cervical disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in patients undergoing anterior cervical discectomy and fusion for cervical spondylosis. Additionally, to compare the level of degenerative cervical disc glycosylation in patients with and without diabetes.

Hypothesis: Patients with diabetes and degenerative cervical disc disease have higher levels of disc tissue glycosylation, and higher levels of glycosylation are correlated with poor outcomes.

Description:

Spine surgery has increased substantially in the U.S. during the past decade, with an estimated 100,000 patients undergoing cervical procedures annually. As the demographics of an aging population begin to increase their utilization of healthcare resources, surgeons will undoubtedly be faced with an increasing number of high-risk patients. A number of factors including smoking, obesity, and diabetes significantly contribute to surgical complications following spinal arthrodesis. Nicotine has a direct inhibitory effect on autologous cancellous bone graft revascularization, significantly increasing the rate of bony non-union. Similarly, obesity has been demonstrated to represent a significant risk factor for subsequent pseudoarthrosis and has been linked to nearly a 100% higher in-hospital complication rate. Spine instrumentation in the setting of diabetes has been linked to reduced incidence of bony fusion, increased surgical site infection9, and higher hospital costs.

Achieving solid bony fusion following cervical arthrodesis has long been considered the most important primary outcome measure and is highly correlated with patient reported outcome measures. Non-union or pseudoarthrosis following cervical instrumentation can lead to persistent neck pain and/or recurrence of myeloradiculopathy. The incidence of bony fusion is affected by both patient systemic factors and local biologic environment. Significant resources have been invested into studying local environment following spinal arthrodesis, with a particular focus on high-risk patients. Animal studies have suggested diabetes is a significant risk factor for disc degeneration, yet corresponding human studies are lacking. Understanding the mechanism by which diabetes contributes to disc degeneration is the first requisite step in designing therapies to prevent diabetes associated disc degeneration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75

• A diagnosis of type I or type II diabetes mellitus (diabetes cohort only)

• Clinical diagnosis of cervical myelopathy or cervical spondylosis

• Requiring anterior cervical discectomy and fusion

• Able to cooperate in the completion of standardized outcome measures (NDI)

• Willing and able to comply with study protocol

• Control patients will fulfill all eligibility criteria with the exception of diagnosis of diabetes.

Exclusion Criteria:

• Pre-existent neurologic disorder or mental disorder that would preclude accurate evaluation (psychiatric disease, Parkinson's disease, Alzheimer's disease)

• History of previous anterior cervical fusion adjacent to the operative site

• Osteoporosis

• Rheumatoid arthritis

• Pregnancy

• Active malignancy

• History of previous posterior cervical decompression

Related Conditions & MeSH terms

• Cervical Myelopathy
• Cervical Spondylosis
• Diabetes
• Diabetes Mellitus
• Spinal Cord Diseases
• Spondylosis

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Disc Glycosylation Levels	After extraction during surgery, the intervertebral disc will be sent in saline to the lab for glycosylation analysis. Glycosylation refers to the chemical bonds of blood glucose to the red blood cells. Normally, only a small percentage of blood glucose, usually between 4.5%- 6%, is covalently linked to the red blood cells in hemoglobin of the non diabetes population.	One-time, measured at time of surgery
Secondary	Neck Disability Index (NDI)	Questionnaire to determine how subject's neck pain has affected their ability to manage in everyday life. Scores are calculated. Low scores indicate less pain/less disability. High scores indicate more pain/more disability. Scores range from 0-100.	24 months
Secondary	Rates of Fusion	Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post- operatively.	24 months