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Completed

NCT Number: NCT01593397

Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine, Department of Anesthesia

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol and Fentanyl administration

Drug

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.

Other names: anesthetic administration

Primary outcomes

  1. plasma concentration of drugs fentanyl and propofol

    Time frame: measured for 12 hours (beginning of anesthesia to 12 hours after)

    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 outcomes

  1. Adiponectin plasma protein levels

    Time frame: measured once (immediately before the operation)

    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.

  2. Adiponectin gene polymorphisms

    Time frame: measured once per study (immediately before the operation)

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 8, 2012
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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