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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01025609

Collaborator

University of Minnesota (Other)

134

Enrollment

Location

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Spinal Cord Injury

Detailed Description

This study is a cross-sectional study. It 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.

Study Design

Study Type:

Observational

Actual Enrollment :

134 participants

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Outcome Measures

Primary Outcome Measures

Whole-grain intake [Day - 30]
Average number of whole grain servings per day
Fruit and vegetable intake [Day - 30]
Average number of fruit and vegetable servings per day
Dairy intake [Day - 30]
Average number of dairy servings per day

Secondary Outcome Measures

Waist circumference [Year 1]
Total cholesterol [Year 1]
HDL-C [Year 1]
LDL-C [Year 1]
Triglycerides [Year 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Rehabilitation	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

Wake Forest University Health Sciences
University of Minnesota

Investigators

Principal Investigator: Pamela Shreiner, PhD, University of Minnesota
Study Director: Jesse A. Lieberman, M.D., Carolinas Rehabilitation/Carolinas Medical Center