Dietary Patterns and Cardiovascular (CVD) Risk in Spinal... | NCT01025609

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

NCT01025609

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Jun 29, 2022Actual

Enrollment

134Actual

Phase

Not provided

Conditions

Spinal Cord Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2022

Last Update Posted Date

Jun 29, 2022Actual

Name	Class
University of Minnesota	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Waist circumference		Year 1
Total cholesterol		Year 1
HDL-C

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

100 individuals with chronic spinal cord injuries

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carolinas Rehabilitation		Charlotte	North Carolina	28203	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24621049	Derived	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.

ID	Term
D013119	Spinal Cord Injuries
D002318	Cardiovascular Diseases

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System