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NCT02034331 · ClinicalTrials.gov registry record · NA
IR and Microvascular Blood Flow in SCI
A NA study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
NCT02034331 is a NA study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 68 participants.
The verdict
NCT02034331, a NA study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
Study Summary
Persons with spinal cord injury (SCI) are at an increased risk for metabolic disorders, including that of insulin resistance. As a result of neurological injury, they often have impaired mechanisms that regulate blood vessel function below the level of injury. Insulin, which facilitates the transport of glucose into muscle cells, is also capable of regulating skin blood flow, with insulin resistance reducing perfusion. Although beyond the scope of this proposal, the possibility exists that impaired microvascular skin blood flow responses due to insulin may further predispose to ischemia of the skin at pressure points of bony prominence. This perturbed cutaneous vascular response may place persons with SCI at risk for the development and poor healing of pressure ulcers due to microvascular dysfunction secondary to neurologic and metabolic disorders. Primary Aim: To determine the association between systemic insulin sensitivity and insulin-mediated vasodilatation below the neurological level of injury. We hypothesize that individuals with systemic insulin sensitivity compared to those with insulin resistance will have greater insulin-mediated vasodilatation and an associated proportional increase in cutaneous blood perfusion. Thus, intact and appropriate endothelial-mediated regulation by insulin will be operative despite sub-lesional neurological impairment in insulin sensitive individuals with SCI. However, because of the absence of the SNS-mediated insulin action on the microvasculature (i.e., insulin-mediated sympathetic withdrawal), it is being hypothesized that the vasodilatory response to iontophoresis with insulin in insulin sensitive subjects with SCI will be less than that observed in neurologically intact controls with insulin sensitivity. Secondary Aim: To compare peak microvascular perfusion responses to endothelial-dependent vasodilatation by iontophoresis with acetylcholine to insulin. We hypothesize that the peak blood perfusion responses to iontop
Interventions
- DRUG Insulin iontophoresis
- DRUG Placebo Iontophoresis
- DRUG Acetylcholine Iontophoresis
- OTHER Heat application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02034331
The ClinicalTrials.gov registry entry for NCT02034331 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Insulin iontophoresis is the first listed.
NCT02034331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02034331 about?
NCT02034331 is a clinical study titled "IR and Microvascular Blood Flow in SCI". Persons with spinal cord injury (SCI) are at an increased risk for metabolic disorders, including that of insulin resistance. As a result of neurological injury, they often have impaired mechanisms that regulate blood vessel function below the level of injury. Insulin, which facilitates the transpor...
What is the current status of trial NCT02034331?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2012-12. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02034331?
The interventions under investigation include: Insulin iontophoresis (DRUG), Placebo Iontophoresis (DRUG), Acetylcholine Iontophoresis (DRUG), Heat application (OTHER).
Who is sponsoring clinical trial NCT02034331?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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