Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury (SCIDS)

This study has been completed.
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Jesse Lieberman, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01025609
First received: December 2, 2009
Last updated: September 7, 2012
Last verified: September 2012

December 2, 2009
September 7, 2012
September 2009
July 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01025609 on ClinicalTrials.gov Archive Site
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Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Dietary Patterns & There Relationship to Cardiovascular Disease Risk Factors In Individuals With Chronic Spinal Cord Injury

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

100 individuals with chronic spinal cord injuries

Spinal Cord Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria

  • 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
  • Injury < 1 years prior to enrollment
  • ASIA D
  • Chronic, nontobacco substance-abuse
Both
38 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01025609
04-09-17E
Yes
Jesse Lieberman, Carolinas Healthcare System
Carolinas Healthcare System
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Pamela Shreiner, PhD University of Minnesota - Clinical and Translational Science Institute
Study Director: Jesse A. Lieberman, M.D. Carolinas Rehabilitation/Carolinas Medical Center
Carolinas Healthcare System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP