We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01593397
First Posted: May 8, 2012
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Jerry Ingrande, Stanford University
  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: Intervention Model: Single Group Assignment
Masking: None (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 Jerry Ingrande, 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) ]

    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) ]
    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) ]
    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.


Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593397


Locations
United States, California
Stanford University School of Medicine, Department of Anesthesia
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Jerry Ingrande, M.D., M.S. Stanford University
  More Information

Responsible Party: Jerry Ingrande, Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT01593397     History of Changes
Other Study ID Numbers: 1K23GM100273-01 ( U.S. NIH Grant/Contract )
5K23GM100273-04 ( U.S. NIH Grant/Contract )
First Submitted: April 30, 2012
First Posted: May 8, 2012
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: pharmacokinetic models will be published after data analysis and study completion

Keywords provided by Jerry Ingrande, Stanford University:
Obesity
Insulin Resistance

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