N/A
N=59
Ischemia/Reperfusion Injury of Human Endothelium: Role of Glucose and Statins
Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00995670 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Forearm Blood Flow — 6.48; 9.2; 7.32; 8.26 ml/100 ml tissue/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 5% dextrose (Drug); Vitamin C (Drug); Simvastatin (Drug); Sevoflurane (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forearm Blood Flow |
6.48; 9.2; 7.32; 8.26; 9.2; 9.91 | — |
Summary
Anesthetic preconditioning (APC, a brief exposure to an anesthetic gas) has become an area of intense research interest because of its ability to protect tissue and organs from injury resulting from a cessation of blood flow and then a re-establishment of flow. The blood vessel lining plays a key role in this injury. This research will examine, in human volunteers, several important modifiers of APC in human blood vessels: high blood sugar, vitamin C, and statin drugs. Thus, the proposed studies will advance the investigators' understanding of mechanisms of this injury in humans and explore important modifiers of APC protection from injury.
Eligibility Criteria
Inclusion Criteria
- Young, healthy volunteers, 18-35 yr of age;
- Females will be studied at the same phase of their estrous cycle in each protocol.
Exclusion Criteria
- Beta-blocker therapy or any medication that might interfere with vascular responses;
- Pregnant or lactating women;
- Substance abusers;
- Smokers;
- Anyone with cardiovascular, renal, or other systemic disease including hypertension and/or diabetes;
- Also excluded are volunteers with family history of malignant hyperthermia, or significant gastro-esophageal reflux.
Data sourced from ClinicalTrials.gov (NCT00995670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.