Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men

This study has been completed.

First Received on September 13, 2005. Last Updated on October 10, 2006 History of Changes

Sponsor:	TNO Quality of Life
Information provided by:	TNO Quality of Life
ClinicalTrials.gov Identifier:	NCT00221052

Purpose

Overweight increases the risk to develop chronic diseases including type-2 diabetes and cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects is thought to play an important role in disease development.

The purpose of this study is to determine the role of inflammation on 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 will be studied.

Condition	Intervention
Overweight Obesity Inflammation	Drug: Diclofenac

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by TNO Quality of Life:

Estimated Enrollment:	20
Study Start Date:	June 2005
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Body Mass Index (BMI): 25.1 – 32.0 kg/m2
Normal Dutch eating habits

Exclusion Criteria:

diabetes, cardiovascular disease or hypertension
Not suitable to receive diclofenac treatment
Smoking
Extreme physical activity (more than 6 hours/week)
Reported slimming or medically prescribed diet

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221052

Locations

Netherlands
TNO Quality of Life
Zeist, Netherlands, 3700 AJ

Sponsors and Collaborators

TNO Quality of Life

Investigators

Principal Investigator:

Trinette van Vliet, PhD

TNO Quality of Life, Location Zeist

More Information

No publications provided by TNO Quality of Life

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van Erk MJ, Wopereis S, Rubingh C, van Vliet T, Verheij E, Cnubben NH, Pedersen TL, Newman JW, Smilde AK, van der Greef J, Hendriks HF, van Ommen B. Insight in modulation of inflammation in response to diclofenac intervention: a human intervention study. BMC Med Genomics. 2010 Feb 23;3:5.

ClinicalTrials.gov Identifier:	NCT00221052 History of Changes
Other Study ID Numbers:	TNO-P6374
Study First Received:	September 13, 2005
Last Updated:	October 10, 2006
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:

Inflammation
Obesity
Overweight
Pathologic Processes
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012