Effect of Reduction of Inflammatory Status on Glucose Met... | NCT00221052

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

NCT00221052

Sponsor

TNO

Status

Completed

Last Update Posted

Oct 11, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Overweight
Obesity
Inflammation

Interventions

Diclofenac

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2006

Last Update Posted Date

Oct 11, 2006Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Trinette van Vliet, PhD	TNO Quality of Life, Location Zeist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TNO Quality of Life		Zeist		3700 AJ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20178593	Derived	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. doi: 10.1186/1755-8794-3-5.

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Term
D050177	Overweight
D009765	Obesity
D007249	Inflammation