A Natural History of Perioperative Metabolism

NCT04396964 | Completed

• 1 other identifier: M14-291
• Study Type: observational
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• glucose

  glucose concentrations

  perioperative

• insulin

  insulin concentrations

  perioperative

• c-peptide

  c-peptide concentrations

  perioperative

• cortisol

  cortisol concentrations

  perioperative

Study Arms (1)

surgery

subjects undergoing multilevel lumbar fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing multilevel lumbar fusion with an inhaled anesthetic.

You may qualify if:

• Subjects were eligible if they were \>18 years old without acute or chronic health conditions who were undergoing multilevel lumbar fusions with an inhaled anesthetic.

You may not qualify if:

• acute or chronic health conditions including cardiac, pulmonary, hepatic, renal, auto-immune, or hematological disease. Obese subjects with body mass index \>40kg/m2 were excluded. Subjects with Type 2 diabetes were eligible if they were well-controlled (HbA1c \<7.5%) and treated with diet and exercise, metformin, or insulin. Subjects were excluded if taking a sulfonylurea, thiazolidindiones, DPP-4 inhibitor, GLP-1 analog, weight loss medication, or other medications affecting glucose homeostasis.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: April 14, 2014
• Primary Completion: November 3, 2016
• Study Completion: July 31, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share