OverweightNCT00221052
Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men
A study testing Diclofenac in people with Overweight and Obesity, run by TNO at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Inflammation
- What is being tested?
- Diclofenac
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2005to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI): 25.1 - 32.0 kg/m2
- Normal Dutch eating habits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men
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.
- Conditions
- Overweight, Obesity, Inflammation
- Being tested
- Diclofenac
- Medical subject headings
- Overweight, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Investigators
- Trinette van Vliet, PhD, Principal investigator, TNO Quality of Life, Location Zeist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221052
- Sponsor's protocol ID
- TNO-P6374
- Status last verified
- Oct 2006
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Publications
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.
PubMed 20178593
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men
- ClinicalTrials.gov ID
- NCT00221052
- Acronym / sponsor ID
- TNO-P6374
- Conditions
- Overweight, Obesity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- TNOUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jul 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI): 25.1 - 32.0 kg/m2
- Normal Dutch eating habits
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
- Derived from this study: PubMed 20178593van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trinette van Vliet, PhD principal investigator
TNO Quality of Life, Location Zeist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac in people with Overweight and Obesity, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2006.