Status:
COMPLETED
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
Lead Sponsor:
University of Miami
Conditions:
Overweight
Obese
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine how exercise and nutritional guidance and supplementation affects your physical fitness, risk for heart disease, your body's ability to burn fat, and your opi...
Detailed Description
The study plan will enroll 80 persons with Spinal Cord Injury (SCI) who are overweight/obese and have fasting atherogenic dyslipidemia and dysglycemia. A Data Safety Management Board will oversee the ...
Eligibility Criteria
Inclusion
- participants will include 64 men and women aged 18-65 years with SCI (AIS A-C) at the C5-L1 levels for more than 1 year.
- the International Standards for Neurological Classification of SCI (ASIA/ISCoS) will serve as benchmarks for subject classification. A physician-rater experienced in these procedures will classify subjects upon study entry.
Exclusion
- Study candidates will be excluded from study because of:
- structured exercise conditioning for recreation or competition within 6 months of study entry;
- defined diet involving caloric restriction or nutrient modification;
- weight loss or gain of 5% within the preceding 6 months;
- surgery within 6 months;
- pressure ulcer within 3 months;
- upper limb pain that limits exercise;
- recurrent acute infection or illness requiring hospitalization or IV antibiotics;
- pregnancy;
- previous MI or cardiac surgery;
- 6 month history of glucose-lowering and lipid-lowering drug therapy;
- Type I or II diabetes (by WHO criteria); and
- daily intake of vitamin supplements exceeding 100% RDA.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01467817
Start Date
September 1 2010
End Date
September 1 2016
Last Update
November 30 2016
Active Locations (1)
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1
University Of Miami
Miami, Florida, United States, 33136