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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
History of Changes
  Purpose

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.


Condition
Spinal Cord Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Dietary Patterns & There Relationship to Cardiovascular Disease Risk Factors In Individuals With Chronic Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carolinas Healthcare System:

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   38 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

100 individuals with chronic spinal cord injuries

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025609

Locations
United States, North Carolina
Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
University of Minnesota - Clinical and Translational Science Institute
Investigators
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
  More Information

No publications provided

Responsible Party: Jesse Lieberman, Mentored Principal Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01025609     History of Changes
Other Study ID Numbers: 04-09-17E
Study First Received: December 2, 2009
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
spinal cord injury
cardiovascular disease
dietary patterns

Additional relevant MeSH terms:
Cardiovascular Diseases
Retinitis Pigmentosa
Spinal Cord Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
 Retinal Diseases
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013