Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT01203150
Eligibility Criteria:
Inclusion Criteria:
* SCI resulting in paraplegia between T5 and L1
* injury for more than one year
* American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries
* BMI ≥ 23 kg/m2 (defined by studies as the equivalent to the WHO criterion of 25 kg/m2 as 'overweight', and the point at which health risks begin to increase), plus any two or more of the following conditions on screening:
1. prehypertension (BP ≥ 120/80 mmHg) by updated AHA and ADA criteria
2. dyslipidemia (HDL-C ≥ 40 mg/dL or TG ≤ 150 mg/dL) by NCEP ATP III Guidelines,44 or
3. impaired fasting glucose (≥ 100 mg/dL) by 2006 ADA criteria.
Exclusion Criteria:
* 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 myocardial infarction or cardiac surgery
* 6 month history of glucose lowering and lipid-lowering drug therapy
* Type I or II diabetes (by WHO criteria)
* daily intake of vitamin supplements exceeding 100% RDA
* The following medications and drug therapies will disqualify subjects from participating: beta-adrenergic antagonists, maintenance alpha-blockers, Methyldopa, thiazide and loop diuretics, parasympatholytic agents, zinc, estrogen/hormone replacement therapy excluding oral contraceptives, insulin-sensitizing drugs, and maintenance use of aspirin and nonsteroidal anti-inflammatory drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01203150
Study Brief:
Protocol Section:
NCT01203150