Trial Outcomes & Findings for Diabetes and Glycosylation in Cervical Spondylosis (NCT NCT02758899)

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

21 participants

Primary outcome timeframe

One-time, measured at time of surgery

Results posted on

2021-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	11	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetic Patients n=9 Participants 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 n=9 Participants Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=9 Participants	7 Participants n=9 Participants	12 Participants n=18 Participants
Age, Categorical >=65 years	4 Participants n=9 Participants	2 Participants n=9 Participants	6 Participants n=18 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	7 Participants n=9 Participants	9 Participants n=18 Participants
Sex: Female, Male Male	7 Participants n=9 Participants	2 Participants n=9 Participants	9 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	9 participants n=9 Participants	18 participants n=18 Participants

PRIMARY outcome

Timeframe: One-time, measured at time of surgery

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.

Outcome measures

Outcome measures
Measure	Diabetic Patients n=9 Participants 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 n=9 Participants Patients with no diagnosis of diabetes, with a clinical diagnosis of cervical myelopathy or cervical spondylosis requiring anterior cervical discectomy and fusion.
Absolute Disc Glycosylation Levels	0.0528 R2 of glycosylation in the disc	0.44065 R2 of glycosylation in the disc

SECONDARY outcome

Timeframe: 24 months

Population: Neck Disability Index questionnaires were given to all patients in the study pre-operatively and at set intervals post-operatively. The study ended earlier than originally anticipated. The number of questionnaires that were completed were not enough to do a thorough analysis.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Diabetic Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wilson Z. Ray

Washington University

Phone: 314-747-6145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place