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

NCT01025609 | Completed DMC

• 1 other identifier: 04-09-17E
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; cardiovascular disease; dietary patterns

Outcome Measures

Primary Outcomes (3)

• Whole-grain intake

  Average number of whole grain servings per day

  Day - 30

• Fruit and vegetable intake

  Average number of fruit and vegetable servings per day

  Day - 30

• Dairy intake

  Average number of dairy servings per day

  Day - 30

Secondary Outcomes (5)

• Waist circumference

  Year 1

• Total cholesterol

  Year 1

• HDL-C

  Year 1

• LDL-C

  Year 1

• Triglycerides

  Year 1

Eligibility Criteria

• Age: 38 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 individuals with chronic spinal cord injuries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of Minnesota: collaborator

Study Sites (1)

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

• Lieberman J, Goff D Jr, Hammond F, Schreiner P, Norton HJ, Dulin M, Zhou X, Steffen L. Dietary intake and adherence to the 2010 Dietary Guidelines for Americans among individuals with chronic spinal cord injury: a pilot study. J Spinal Cord Med. 2014 Nov;37(6):751-7. doi: 10.1179/2045772313Y.0000000180. Epub 2014 Jan 3.

  PMID: 24621049 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Pamela Shreiner, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Jesse A. Lieberman, M.D.

  Carolinas Rehabilitation/Carolinas Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 29, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)