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

This study has been completed.

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

Sponsored by:	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:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Obesity
Cyclooxygenase Inhibitors
Diclofenac
Overweight
Healthy
Inflammation
Body Weight

Signs and Symptoms
Analgesics, Non-Narcotic
Nutrition Disorders
Overnutrition
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Obesity
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Overweight
Pharmacologic Actions
Inflammation
Body Weight
Signs and Symptoms

Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nutrition Disorders
Overnutrition
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009