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Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

This study is currently recruiting participants.
Verified May 2012 by Stanford University
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Jerry Ingrande, Stanford University
ClinicalTrials.gov Identifier:
NCT01593397
First received: April 30, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Drug: Propofol, Fentanyl

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • plasma concentration of drugs fentanyl and propofol [ Time Frame: measured for 12 hours (beginning of anesthesia to 12 hours after) ] [ Designated as safety issue: Yes ]

    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 to loss of conciousness [ Time Frame: measured once per study (at the time of induction of anesthesia) ] [ Designated as safety issue: Yes ]
    The time from propofol and fentanyl administration (time 0) until loss of consciousness will be measured in order to measure a component of drug response.

  • partial pressure of carbon dioxide in blood [ Time Frame: measured once immediately before the operation and approximately every 30 minutes for 3 hours after the operation ] [ Designated as safety issue: Yes ]
    The investigators will measure arterial blood gases to obtain blood carbon dioxide partial pressures as a measure of respiratory depression caused by fentanyl.


Secondary Outcome Measures:
  • Adiponectin plasma protein levels [ Time Frame: measured once (immediately before the operation) ] [ Designated as safety issue: No ]
    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 [ Time Frame: measured once per study (immediately before the operation) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol and Fentanyl administration
Propofol and Fentanyl will be administered to each subject. Each subject 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.
 Drug: Propofol, Fentanyl
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593397

Contacts
Contact: Jerry Ingrande, M.D., M.S. 650-723-7377 jerryi@stanford.edu

Locations
United States, California
Stanford University School of Medicine, Department of Anesthesia Recruiting
Stanford, California, United States, 94305
Contact: Jerry Ingrande, M.D., M.S.     650-723-7377     jerryi@stanford.edu    
Sponsors and Collaborators
Stanford University
National Institute of General Medical Sciences (NIGMS)
  More Information

No publications provided

Responsible Party: Jerry Ingrande, Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT01593397     History of Changes
Other Study ID Numbers: 1K23GM100273-01
Study First Received: April 30, 2012
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Obesity
Insulin Resistance

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fentanyl
Propofol
Insulin
Adjuvants, Anesthesia
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypoglycemic Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on June 18, 2013