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Study [Diclofenac] study / subjects / design / samples / assays

Basic properties of your study This page shows the basic information about your study, as well as information on the authorizations.

Publications

Contacts

  • Vliet, Trinette
    Principle Investigator

Authorization

Public Design
Yes
Readers
peter.wielinga
jildau.bouwman
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Writers
Study title
Diclofenac - Relation between reduction of the inflammatory status and glucose metabolism in healthy overweight men
Template
Intervention/Observation study
title
Diclofenac - Relation between reduction of the inflammatory status and glucose metabolism in healthy overweight men
description
"To study the metabolic changes induced by a mild anti-inflammatory drug intervention (diclofenac), plasma metabolic profiling was applied in overweight human volunteers with elevated levels of the inflammatory plasma marker C-reactive protein. Liquid and gas chromatography mass spectrometric methods were used to detect high and low abundant plasma metabolites both in fasted conditions and during an oral glucose tolerance test. The study was designed as a double blind, randomized, parallel trial, in which subjects were treated with diclofenac (n=10) or placebo (n=10)."
code
Diclofenac
startDate
2012-06-20 00:00:00.0
Study type
Human Intervention
Objectives
The purpose of this study was to determine the role of inflammation in glucose metabolism and insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on markers of inflammation and on parameters of glucose metabolism was studied. 1. To investigate the effects of a reduction of low-grade inflammatory status on: - standard physiological parameters of inflammation and glucose metabolism - gene expression in relation to glucose metabolism, to identify possible new candidate biomarkers - metabolite profiles in relation to glucose metabolism, to identify possible new candidate biomarkers 2. To investigate the mechanism of action of diclofenac on inflammatory status using gene expresion and metabolism
Central conclusion
In this study the integrated analysis of a wide range of parameters allowed the development of a network of markers responding to inflammatory modulation, thereby providing insight into the complex process of inflammation and ways to assess changes in inflammatory status associated with obesity. Metabolic changes were subtle and were only detected using metabolic profiling in combination with an oral glucose tolerance test. The repeated measurements during the oral glucose tolerance test increased statistical power, but the metabolic perturbation also revealed metabolites that respond differentially to the oral glucose tolerance test. Specifically, multiple metabolic intermediates of the glutathione synthesis pathway showed time-dependent suppression in response to the glucose challenge test. The fact that this is an insulin sensitive pathway suggests that inflammatory modulation may alter insulin signaling in overweight men.
Exclusion criteria
smoking, alcohol consumption >28 units/week, having a history of medical or surgical events that may affect study outcome (including diabetes, CVD, hypertension), use of interfering medication, anamnesis not suitable to receive diclofenac
Inclusion criteria
Healthy, Male, age 18-60 years, BMI 25.1-34.0 kg/m2
Institute
TNO Quality of Life, Zeist, The Netherlands
Consortium
not defined
Study protocol
P6374-revised-final-13mei05.pdf

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