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

This study has been completed.
Sponsor:
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00221052
First received: September 13, 2005
Last updated: October 10, 2006
Last verified: October 2006
  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:


Further study details as provided by TNO:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Trinette van Vliet, PhD TNO Quality of Life, Location Zeist
  More Information

No publications provided by TNO

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 22, 2014