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A Natural History of Perioperative Metabolism

NCT04396964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2020-05-21

No results posted yet for this study

Summary

The process of surgery is a controlled trauma to the body. Trauma induces changes in metabolic function that have evolved to help the body survive injury. The normal balance among use of sugar, fat, and protein for energy production is thought to change during trauma and surgery. This altered metabolic function may contribute to adverse outcomes from surgical procedures especially in the setting of patients with obesity or Type 2 Diabetes Mellitus. However, very little is known about the specific changes in metabolism that occur during surgical procedures.

The main objective of this project is to describe the metabolic changes that occur during a typical surgical procedure in detail. In order to measure the alterations in the balanced use of sugar, fat, and protein during surgery we will collect blood samples from patients before, during, and after spinal surgical procedures. Subjects will be enrolled in the pre-operative hold area, give informed consent, and have a dedicated peripheral IV catheter placed. We will recruit patients who are normal weight without diabetes, obese without diabetes, and obese with diabetes. The first specific aim is to characterize the metabolic changes in sugar, fat, and protein balance during surgery in metabolically normal subjects. The second specific aim to examine if there are differences in these changes in subjects who are obese or have diabetes. The final specific aim is to measure the changes in metabolism at high resolution using a method called metabolomics, which is analogous to genome profiling. This method measures hundreds of compounds produced in different amounts as metabolic balance changes.

The major impacts that may be derived from these data range from a more thorough understanding of metabolism under trauma to identification of new markers for risk stratification and intervention to improve clinical outcomes. These data will help build the foundation for new approaches to understanding the physiological and metabolic responses to stress and trauma.

Conditions

  • Surgery
  • Anesthesia
  • Insulin Sensitivity
  • Metabolic Stress Hyperglycemia

Sponsors & Collaborators

  • University of Vermont Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-14
Primary Completion
2016-11-03
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396964 on ClinicalTrials.gov