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Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jerry Ingrande, Stanford University
ClinicalTrials.gov Identifier:
NCT01593397
First received: April 30, 2012
Last updated: November 17, 2014
Last verified: November 2014
  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 and Fentanyl administration

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:


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.



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
No Intervention: Propofol and Fentanyl administration
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.
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.
Other Name: anesthetic administration

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Jerry Ingrande, M.D., M.S. Stanford University
  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, 5K23GM100273-04
Study First Received: April 30, 2012
Last Updated: November 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Obesity
Insulin Resistance

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

ClinicalTrials.gov processed this record on November 20, 2014