Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
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|ClinicalTrials.gov Identifier: NCT01593397|
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Propofol and Fentanyl administration||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
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
- 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.
- 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.
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
|United States, California|
|Stanford University School of Medicine, Department of Anesthesia|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jerry Ingrande, M.D., M.S.||Stanford University|