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Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

NCT ID: NCT01593397

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Keywords

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Obesity Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Propofol and Fentanyl administration

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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anesthetic administration

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jerry Ingrande

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry Ingrande, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine, Department of Anesthesia

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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5K23GM100273-04

Identifier Type: NIH

Identifier Source: secondary_id

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1K23GM100273-01

Identifier Type: NIH

Identifier Source: org_study_id

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