Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

Obesity Clinical Trial

Official title:

Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593397
• Other study ID #: 1K23GM100273-01
• Secondary ID: 5K23GM100273-04
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2012
• Last updated: December 27, 2017
• Start date: November 2011
• Est. completion date: September 2017

Study information

• Verified date: December 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• Propofol and Fentanyl administration
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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine, Department of Anesthesia	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	measured for 12 hours (beginning of anesthesia to 12 hours after)
Secondary	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.	measured once (immediately before the operation)
Secondary	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.	measured once per study (immediately before the operation)