Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity

NCT01593397 | Completed Phase 1 DMC

• 2 other identifiers: 1K23GM100273-015K23GM100273-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• plasma concentration of drugs fentanyl and propofol

  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 Outcomes (2)

• Adiponectin plasma protein levels

  measured once (immediately before the operation)

• Adiponectin gene polymorphisms

  measured once per study (immediately before the operation)

Study Arms (1)

Propofol and Fentanyl administration

EXPERIMENTAL

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

Interventions

Propofol and Fentanyl administration 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.

Also known as: anesthetic administration

Propofol and Fentanyl administration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Class I, II, or III, and undergoing elective surgical procedures requiring general anesthesia
• Body mass index greater than 35

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Stanford University School of Medicine, Department of Anesthesia

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Propofol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jerry Ingrande, M.D., M.S.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 8, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 29, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)