SurgeryNCT04396964
A Natural History of Perioperative Metabolism
An observational study of Surgery and Anesthesia, run by University of Vermont Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Anesthesia, Insulin Sensitivity
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2014to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing multilevel lumbar fusion with an inhaled anesthetic.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed description
We will conduct a cross-sectional study in a cohort of patients undergoing spinal surgery for discectomy, laminectomy, or vertebral fixation. We will recruit a cohort of subjects in groups with metabolic phenotypes defined by body mass index (BMI) and glycemic control. We are choosing to use spinal surgeries as they utilize inhaled anesthetics, run hours in length, do not involve ischemic tourniquet time, and use basic elements of the anesthetic pharmacopeia including anti-emetics, opioid analgesics, and paralytics. Further the increased surgical stress of entering the thorax or peritoneum are avoided. These features provide a long steady-state of surgical intervention with minimal additional maneuvers allowing for a controlled examination of surgical metabolism.
The categorical criteria for the groups will be body type: lean (BMI<25), overweight (BMI >25, <30), and obese (BMI >30 but <40), and glycemia: normoglycemic (fasting blood glucose; FBG <100 mg/dL or HbA1c <5.5%), impaired fasting glucose (FBG >100 mg/dL and <126 mg/dL, or HbA1c >5.5% and <6.5%), Type 2 Diabetes (FBG >126 mg/dL or HbA1c >6.5%).
Subjects will be screened, enrolled, give informed consent, and have a dedicated peripheral IV line placed in pre-operative hold. A baseline blood sample will be collected in pre-operative hold, after transfer to the table in the operating room, and immediately prior to induction of anesthesia. Following induction blood samples will be collected at 15' intervals for the initial 2 hours of each case, then at 30' intervals for the remainder of the case and for 2 hours in the post-anesthesia care unit. Samples will be processed and stored at -80C until analyzed. Intra-operative data from the anesthesia record will be collected and included in the study database.
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| surgery | subjects undergoing multilevel lumbar fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose
glucose concentrations
Measured: perioperative
insulin
insulin concentrations
Measured: perioperative
c-peptide
c-peptide concentrations
Measured: perioperative
cortisol
cortisol concentrations
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start14 Apr 2014
- Primary completion3 Nov 2016
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William G Tharp, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396964
- Sponsor's protocol ID
- M14-291
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural History of Perioperative Metabolism
- ClinicalTrials.gov ID
- NCT04396964
- Acronym / sponsor ID
- M14-291
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- 3 Nov 2016 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will conduct a cross-sectional study in a cohort of patients undergoing spinal surgery for discectomy, laminectomy, or vertebral fixation. We will recruit a cohort of subjects in groups with metabolic phenotypes defined by body mass index (BMI) and glycemic control. We are choosing to use spinal surgeries as they utilize inhaled anesthetics, run hours in length, do not involve ischemic tourniquet time, and use basic elements of the anesthetic pharmacopeia including anti-emetics, opioid analgesics, and paralytics. Further the increased surgical stress of entering the thorax or peritoneum are avoided. These features provide a long steady-state of surgical intervention with minimal additional maneuvers allowing for a controlled examination of surgical metabolism.
The categorical criteria for the groups will be body type: lean (BMI<25), overweight (BMI >25, <30), and obese (BMI >30 but <40), and glycemia: normoglycemic (fasting blood glucose; FBG <100 mg/dL or HbA1c <5.5%), impaired fasting glucose (FBG >100 mg/dL and <126 mg/dL, or HbA1c >5.5% and <6.5%), Type 2 Diabetes (FBG >126 mg/dL or HbA1c >6.5%).
Subjects will be screened, enrolled, give informed consent, and have a dedicated peripheral IV line placed in pre-operative hold. A baseline blood sample will be collected in pre-operative hold, after transfer to the table in the operating room, and immediately prior to induction of anesthesia. Following induction blood samples will be collected at 15' intervals for the initial 2 hours of each case, then at 30' intervals for the remainder of the case and for 2 hours in the post-anesthesia care unit. Samples will be processed and stored at -80C until analyzed. Intra-operative data from the anesthesia record will be collected and included in the study database.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | – | –subjects undergoing multilevel lumbar fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing multilevel lumbar fusion with an inhaled anesthetic.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
glucose
Time frame: perioperative
glucose concentrations
insulin
Time frame: perioperative
insulin concentrations
c-peptide
Time frame: perioperative
c-peptide concentrations
cortisol
Time frame: perioperative
cortisol concentrations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Anesthesia, run by University of Vermont Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose (time frame: perioperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.