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

Obesity Clinical Trial

Official title:

Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221052
• Other study ID #: TNO-P6374
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 10, 2006
• Start date: June 2005
• Est. completion date: July 2005

Study information

• Verified date: October 2006
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Overweight

Intervention

Drug:
• Diclofenac

Locations

Country	Name	City	State
Netherlands	TNO Quality of Life	Zeist

Sponsors (1)

Lead Sponsor	Collaborator
TNO

Country where clinical trial is conducted

Netherlands,