Back to resultsAdiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Propofol and Fentanyl administration
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity focused on measuring Obesity, Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria include patients of adult age
- American Society of Anesthesiologists Class I, II, or III, and undergoing elective surgical procedures requiring general anesthesia
- Body mass index greater than 35
Exclusion Criteria:
- Patients with evidence of hepatic, renal, or cardiovascular dysfunction
- History of difficult tracheal intubation, or adverse reaction to anesthesia shall be excluded from the study
- Patients taking prescribed or over-the-counter anxiolytics, narcotics, or sleeping aids, will also be excluded
Sites / Locations
- Stanford University School of Medicine, Department of Anesthesia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Propofol and Fentanyl administration
Arm Description
Propofol and Fentanyl will be administered to all subjects. All subjects will have blood drawn to determine pharmacokinetic variables. Processed EEG will be used to determine pharmacodynamics. Plasma samples will be used to ascertain adiponectin levels and for DNA sampling for analysis of adiponectin single nucleotide polymorphisms.
Outcomes
Primary Outcome Measures
plasma concentration of drugs fentanyl and propofol
Plasma concentration over time will be measured and modeled in order to calculate drug clearance, volume of distribution, area under the curve, and micro rate constants.
Knowledge of these variables will allow safer administration of anesthetic drug administration in the obese population.
Secondary Outcome Measures
Adiponectin plasma protein levels
The investigators will measure specific levels of the protein adiponectin in the blood, to determine if quantitative expression of adiponectin can predict insulin resistance in obesity and drug metabolism and response.
Adiponectin gene polymorphisms
The investigators will look at specific genetic variants of the adiponectin gene to determine if expression of specific variants can predict insulin resistance and changed in drug response and metabolism.
Full Information
NCT ID
NCT01593397
First Posted
April 30, 2012
Last Updated
December 27, 2017
Sponsor
Stanford University
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT01593397
Brief Title
Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
Official Title
Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to determine the influence of insulin resistance on drug metabolism and response in obese subjects. The investigators hypothesize that expression of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin gene can predict the insulin resistance and drug response among obese subjects.
Detailed Description
The following study will hypothesizes that insulin resistance causes changes in drug metabolism, elimination, and effect. We will differentiate the insulin resistant phenotype amongst obese individuals on the basis of both laboratory (fasting insulin, triglycerides, fasting glucose) analysis, and quantitative and qualitative adiponectin expression. We will determine the effect of insulin resistance on the pharmacokinetics and pharmacodynamics of anesthetic induction agents and opioids, using propofol and fentanyl as examples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Insulin Resistance
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol and Fentanyl administration
Arm Type
Experimental
Arm Description
Propofol and Fentanyl will be administered to all subjects. All subjects will have blood drawn to determine pharmacokinetic variables. Processed EEG will be used to determine pharmacodynamics. Plasma samples will be used to ascertain adiponectin levels and for DNA sampling for analysis of adiponectin single nucleotide polymorphisms.
Intervention Type
Drug
Intervention Name(s)
Propofol and Fentanyl administration
Other Intervention Name(s)
anesthetic administration
Intervention Description
Propofol will be administered to all patients via infusion at a dose of 2 mg/kg lean body weight/minute. The infusion will stop once loss of consciousness is reached. Fentanyl will be administered via target controlled infusion to achieve a plasma concentration of 2 ng/ml.
Primary Outcome Measure Information:
Title
plasma concentration of drugs fentanyl and propofol
Description
Plasma concentration over time will be measured and modeled in order to calculate drug clearance, volume of distribution, area under the curve, and micro rate constants.
Knowledge of these variables will allow safer administration of anesthetic drug administration in the obese population.
Time Frame
measured for 12 hours (beginning of anesthesia to 12 hours after)
Secondary Outcome Measure Information:
Title
Adiponectin plasma protein levels
Description
The investigators will measure specific levels of the protein adiponectin in the blood, to determine if quantitative expression of adiponectin can predict insulin resistance in obesity and drug metabolism and response.
Time Frame
measured once (immediately before the operation)
Title
Adiponectin gene polymorphisms
Description
The investigators will look at specific genetic variants of the adiponectin gene to determine if expression of specific variants can predict insulin resistance and changed in drug response and metabolism.
Time Frame
measured once per study (immediately before the operation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria include patients of adult age
American Society of Anesthesiologists Class I, II, or III, and undergoing elective surgical procedures requiring general anesthesia
Body mass index greater than 35
Exclusion Criteria:
Patients with evidence of hepatic, renal, or cardiovascular dysfunction
History of difficult tracheal intubation, or adverse reaction to anesthesia shall be excluded from the study
Patients taking prescribed or over-the-counter anxiolytics, narcotics, or sleeping aids, will also be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Ingrande, M.D., M.S.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine, Department of Anesthesia
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
pharmacokinetic models will be published after data analysis and study completion
Learn more about this trial
Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
We'll reach out to this number within 24 hrs