We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01025609
First Posted: December 3, 2009
Last Update Posted: October 12, 2017
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.
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Jesse Lieberman, Carolinas Healthcare System
  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:


Further study details as provided by Jesse Lieberman, 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

Information from the National Library of Medicine

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:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesse Lieberman, Mentored Principal Investigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01025609     History of Changes
Other Study ID Numbers: 04-09-17E
First Submitted: December 2, 2009
First Posted: December 3, 2009
Last Update Posted: October 12, 2017
Last Verified: July 2015

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

Additional relevant MeSH terms:
Wounds and Injuries
Cardiovascular Diseases
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System