Magnetic Resonance Imaging in High Risk Patients for the Development of Diffuse Idiopathic Skeletal Hyperostosis (DISH)
- Conditions
- Diabetes MellitusHyperostosis, Diffuse Idiopathic SkeletalMetabolic Syndrome
- Interventions
- Diagnostic Test: Thoracic spine x-rays+whole spine MRIDiagnostic Test: blood testsOther: constitutional and demographic data collection
- Registration Number
- NCT03237455
- Lead Sponsor
- HaEmek Medical Center, Israel
- Brief Summary
Diffuse idiopathic skeletal hyperostosis (DISH) is a poorly understood, systemic condition characterized by progressive calcification and ossification of ligaments and entheses. The current classification criteria allow diagnosing the disease in its late course, when significant bony overgrowth already involves the vertebral column and the appendicular skeleton. The research of the pathogenic mechanisms in DISH, is significantly hampered by the late diagnosis resulting from this definition.Based on recent MRI studies in both axial spondyloarthritis (axSpA) and in DISH, it seems that changes similar to the classical early inflammatory changes described in axSpA, can be detected in patients with DISH. We therefore hypothesize, that patients with metabolic syndrome without radiographic evidence for spinal DISH, might exhibit early MRI changes. If this hypothesis proves to be correct, early diagnosis and research of the possible pathogenetic mechanisms at this early stage might be very rewarding in investigations of the early aberrations of the entheses homeostasis and eventually early, more targeted therapeutic interventions. The study will examine MRI changes in patients, in their 5th decade of life, with high risk for the development of DISH (ie diabetes mellitus, metabolic syndrome) compared with patients who don't have this risk.
- Detailed Description
Patient's selection- Patients will be recruited from obesity/metabolic/diabetes clinics and from bariatric surgeries clinics. All patients will have the diagnosis of metabolic syndrome National Cholesterol Education Panel III (NCEP). Patients in their 5th decade of life will be recruited for the study. This study group will have to meet the NCEP 3 criteria for metabolic syndrome and/or have type 2 diabetes mellitus (9). An age and sex matched individuals who do not meet these pre-requisits will serve as a control group.
All asymptomatic patients will undergo postero-anterior and lateral x-rays of the thoracic spine, unless they have postero-anterior or lateral thoracic spine or chest x-rays in the year preceding the recruitment. For patients with back pain, addition of cervical or lumbar spine radiographs will be permitted based on the physician judgement. Patients recruited for the study will have a total spine and sacroiliac MRI (see below) read by radiologists and rheumatologists, expert in musculoskeletal imaging, who will be blinded for the patient's data. The readings of the radiographs and the MRI will be performed in a random order.
All patients and controls will undergo postero anterior and lateral thoracic spine X-rays and MRI of the entire spine and their sacroiliac joints (Spine: sagittal T1-weighted and T2 with fat suppression sequences, SIJ semicoronal T1-weighted and T2 with fat suppression sequences) at study entry.
An accepted scoring system for the interpretation of the MRI studies will be employed for both the spine and the sacroiliac joints.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Meet the NCEP 3 criteria for metabolic syndrome and/or have type 2 diabetes mellitus (9).
Age 40-49 years
- ESR and CRP levels above common levels adjusted for age, gender, and weight.(I have ref for the determination of common CRP levels).
Positive HLA B-27 Personal or family history of Spondyloarthritis, psoriasis or inflammatory arthritis (past or present) Inflammatory back pain as defined by the ASAS definition (age at onset <40y, insidious onset, improvement with exercise, no improvement with rest, pain at night with improvement upon getting up = IBP if 4/5 items are present) (Ref) History of uveitis Plain radiographs with evidence for DISH
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group blood tests Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection study group Thoracic spine x-rays+whole spine MRI Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection study group constitutional and demographic data collection Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection study group blood tests Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection control group Thoracic spine x-rays+whole spine MRI Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection control group constitutional and demographic data collection Thoracic spine x-rays+whole spine MRI blood tests constitutional and demographic data collection
- Primary Outcome Measures
Name Time Method Inflammatory changes in the spine and/or sacroiliac joints 6 months inflammatory bone marrow edema lesions and fatty lesions and the anterior and posterior corners of the spine (Berlin score) as well as for the presence of enthesitis on the posterior elements.
The sacroiliac joints will also be scored according to the Berlin scoring method for the presence of acute and structural inflammatory lesion, including BME, fat metaplasia, erosions, sclerosis, ankylosis. Anterior and posterior extraarticular enthesitis will also be registered
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
HaEmek MC and Chaim Sheba MC
🇮🇱Afula, Israel