Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury (SCIDS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01025609
Recruitment Status :
First Posted : December 3, 2009
Last Update Posted : July 29, 2015
Carolinas Healthcare System
University of Minnesota - Clinical and Translational Science Institute
This study will look at dietary patterns in individuals with chronic spinal cord injuries and the relationship between these dietary patterns and cardiovascular disease risk factors. The study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study. The dietary history from CARDIA will be used. The investigators' primary hypothesis is the following: Greater whole-grain and dietary fiber intake will be favorably associated with adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin, HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been injured >1 year.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
38 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
100 individuals with chronic spinal cord injuries
Male or female, black or white with SCI due to a nonvascular insult that caused an acute spinal cord injury (i.e. traumatic injury, transverse myelitis without a diagnosis of multiple sclerosis, surgical complication, or benign neoplasm) at least 1 year prior to enrollment including ASIA A,B,C
Age at time of enrollment: > 38 years and <55 years (i.e., on or after 38th birthday and before 55th birthday)
Voluntary, informed consent of participant
Participant willing to comply with the testing protocols and questionnaires
Communication and comprehension sufficient for compliance with all testing procedures and measures Exclusion Criteria
SCI of a vascular or malignant etiology
Pregnancy, end-stage renal disease, treatment for cancer except for non-melanoma skin cancer in the past five years