Diabetes and Glycosylation in Cervical Spondylosis

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes; Cervical Myelopathy; Cervical Spondylosis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical diagnosis of cervical myelopathy or cervical spondylosis that require an anterior cervical discectomy and fusion.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Diabetic Patients; Patients with diagnosis of type I or type II diabetes, in addition to clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
Control Patients; Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Anterior cervical discectomy; Anterior cervical fusion
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Diabetes Mellitus; Spinal Cord Diseases; Spondylosis
• Other Study ID Numbers: 201309048