Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

Stanford University

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Propofol and Fentanyl administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01593397

5K23GM100273-04 (U.S. NIH Grant/Contract)

1K23GM100273-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Propofol and Fentanyl administration

Experimental group

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.

Treatment:

Drug: Propofol and Fentanyl administration