Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

December 27, 2017 updated by: Jerry Ingrande, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine, Department of Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • anesthetic administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measured for 12 hours (beginning of anesthesia to 12 hours after)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measured once (immediately before the operation)
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.
measured once per study (immediately before the operation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of General Medical Sciences (NIGMS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (ESTIMATE)

May 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2017

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K23GM100273-01 (NIH)
  • 5K23GM100273-04 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

pharmacokinetic models will be published after data analysis and study completion

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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