Cardiometabolic Risk, Obesity and Cardiovascular Disease in People With Spinal Cord Injury

Completed

Conditions studied: Spinal Cord Injury

In brief

The purpose of this study is to develop and field-test new tools for diagnosis and hazard assessment of cardiometabolic risk (CMR) in people with chronic spinal cord injury (SCI) and to advance the evidence base with much needed information on CMR and cardiovascular disease (CVD) burden in people with SCI. These data can be used to develop screening guidelines for early identification and prevention of CMR in SCI, as well as targeted approaches to primary disease management.

Key facts

Study ID

NCT01204632

Run by

University of Miami

People needed

74

Starts

2010-03-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• traumatic spinal cord injury between C4 and T12
• have a motor complete injury as classified as American Spinal Injury Association Impairment Scale (AIS) grade A or B
• injury for more than 1 year
• no known history of traumatic brain injury, cardiovascular disease or diabetes
• not currently taking any medications to treat cardiovascular disease or diabetes
• have multiple (i.e., 2+) of the following cardiometabolic risk factors:
• fasting triglyceride > 150 mg/dL
• HDLC < 40 mg/dL
• hs-CRP > 3.0
• body fat (by DEXA) >25% for males and 33% for females

You may not qualify if…

• history of allergy or hypersensitivity to fish and/or nuts
• undergoing anticoagulant therapies

Where it is running

• The Miami Project to Cure Paralysis — Miami, Florida, United States

Full record on ClinicalTrials.gov

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