Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00361751 · ClinicalTrials.gov registry record · Phase 2
Substrate Cycling in Energy Metabolism
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00361751 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 40 participants.
The verdict
NCT00361751, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Insulin resistance and hyperglycemia contribute to negative outcomes in burned patients. We will assess insulin sensitivity in traditional terms of glucose metabolism, and with regard to the responsiveness of both muscle and liver protein metabolism, in severely burned patients. Plasma free fatty acid (FFA) and tissue TG levels will be manipulated via inhibition of peripheral lipolysis with nicotinic acid or activation of plasma lipoprotein lipase activity with heparin, stimulation of tissue fatty acid oxidation and thus reduction of tissue TG with the peroxisome proliferate-activated receptor (PPAR) alpha agonist fenofibrate. Methodological approaches will include stable isotope tracer techniques to quantify kinetic responses of protein, glucose and lipid metabolism in vivo, quantification of intracellular stores of TG and glycogen by means of magnetic resonance spectroscopy (MRS), as well as quantitative analysis of tissue levels of active products of fatty acids, key intermediates of the insulin signaling pathway, glycogen, the enzyme activities of citrate synthase and glycogen synthase and the activity of the muscle mitochondria. These studies will clarify the physiological and clinical significance of the alterations of tissue lipid metabolism that occur after burn injury, thereby forming the basis for new therapeutic approaches not only in this specific clinical condition but in other clinical circumstances in which hepatic and/or muscle TG is elevated. We will investigate the general hypothesis that the accumulation of intracellular TG in liver and muscle either directly causes insulin resistance in those tissues or serves as an indictor of the intracellular accumulation of active fatty acid products, such as fatty acyl CoA and diacylglycerol, which in turn disrupt insulin action. The following specific hypotheses will be investigated: 1. Intracellular TG is elevated in both muscle and liver in severely burned patients. The reduction of the fat in the live
Interventions
- DRUG fenofibrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-05 |
| Est. Completion | 2005-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00361751
The ClinicalTrials.gov registry entry for NCT00361751 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which fenofibrate is the first listed.
NCT00361751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00361751 about?
NCT00361751 is a clinical study titled "Substrate Cycling in Energy Metabolism". Insulin resistance and hyperglycemia contribute to negative outcomes in burned patients. We will assess insulin sensitivity in traditional terms of glucose metabolism, and with regard to the responsiveness of both muscle and liver protein metabolism, in severely burned patients. Plasma free fatty ac...
What is the current status of trial NCT00361751?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2003-05. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00361751?
The interventions under investigation include: fenofibrate (DRUG).
Who is sponsoring clinical trial NCT00361751?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.