ObesityNCT00416156
Effect of Weight Reduction on Inflammatory Markers and Genes Expression in Obese Individuals
A study testing Lifestyle modification in people with Obesity and Inflammation, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To investigate whether weight reduction by life style modification for 12 weeks will improve circulating inflammatory markers, adipocytokines as well as gene expression of proinflammatory protein obtained from circulating monocytes from obese individuals. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2005to Nov 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nondiabetes obese individuals with BMI greater than 27 kgs/m2
Who cannot join
- Diabetes
- Abnormal hepatic, renal and cardiac function
Trial locations and contacts
1 site in 1 country.
About this study
To investigate whether weight reduction by life style modification for 12 weeks will improve circulating inflammatory markers, adipocytokines as well as gene expression of proinflammatory protein obtained from circulating monocytes from obese individuals.
- Conditions
- Obesity, Inflammation
- Being tested
- Lifestyle modification
- Keywords
- Obesity, Inflammation
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory responses after weight reduction
Secondary outcomes (4)
BMI
Circulating inflammatory markers
Adipocytokines
Gene Expression from mononuclear cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startMay 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wayne H Sheu, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416156
- Sponsor's protocol ID
- TCVGH 05082
- Status last verified
- Dec 2006
- First submitted
- 25 Dec 2006
- Last updated
- 27 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Reduction on Inflammatory Markers and Genes Expression in Obese Individuals
- ClinicalTrials.gov ID
- NCT00416156
- Acronym / sponsor ID
- TCVGH 05082
- Conditions
- Obesity, Inflammation
- Keywords
- Obesity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Nov 2005
- First posted
- 27 Dec 2006 (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.
To investigate whether weight reduction by life style modification for 12 weeks will improve circulating inflammatory markers, adipocytokines as well as gene expression of proinflammatory protein obtained from circulating monocytes from obese individuals.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nondiabetes obese individuals with BMI greater than 27 kgs/m2
Key exclusion criteria (2 listed)
- Diabetes
- Abnormal hepatic, renal and cardiac function
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 |
|---|---|---|
| Lifestyle modification | Behavioural | – |
Primary outcome
Inflammatory responses after weight reduction
4 secondary outcomes
BMI
Circulating inflammatory markers
Adipocytokines
Gene Expression from mononuclear cells
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 27 Dec 2006.
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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.
Wayne H Sheu, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Obesity and Inflammation, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 27 Dec 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 Taiwan. 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.
What does the primary outcome measure?
Inflammatory responses after weight reduction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2006.