ObesityNCT00439491
Role of Adipose Tissue in Pathogenesis of Insulin Resistance
A study testing Hypocaloric diet in people with Obesity and Insulin Resistance, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Hypocaloric diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2004to Dec 2006
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obesity
Who cannot join
- Diabetes
- Coronary heart disease
- Eating disorders
- Medication of beta blockers
- Medication of antiobesity drugs
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Third Faculty of Medicine, Charles University in Prague
Prague, 100 00
About this study
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body composition and insulin resistance are measured before and during the diet.
Read the detailed description
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Hypocaloric diet
- Keywords
- Obesity, Insulin resistance, Hypocaloric diet, Adipose tissue, adipocytokine
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body fat
Secondary outcomes (3)
Insulin resistance
Adipocytokine plasma levels
Adipocytokine adipose tissue expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startJan 2004
- Study completionDec 2006
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 Charles University, Czech RepublicThe 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Investigators
- Vladimir Stich, Ass Prof MD PhD, Principal investigator, Third Faculty of Medicine, Charles Uniersity in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439491
- Sponsor's protocol ID
- 303040158
- Status last verified
- Feb 2007
- First submitted
- 21 Feb 2007
- Last updated
- 23 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adipose Tissue in Pathogenesis of Insulin Resistance
- ClinicalTrials.gov ID
- NCT00439491
- Acronym / sponsor ID
- 303040158
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Obesity, Insulin resistance, Hypocaloric diet, Adipose tissue, adipocytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2006
- First posted
- 23 Feb 2007 (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.
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body composition and insulin resistance are measured before and during the diet.
Detailed description
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obesity
Key exclusion criteria (5 listed)
- Diabetes
- Coronary heart disease
- Eating disorders
- Medication of beta blockers
- Medication of antiobesity drugs
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 |
|---|---|---|
| Hypocaloric diet | Behavioural | – |
Primary outcome
Body weight
Body fat
3 secondary outcomes
Insulin resistance
Adipocytokine plasma levels
Adipocytokine adipose tissue expression
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 23 Feb 2007.
- web page of the Third Faculty of MedicineLink provided by the sponsor.
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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.
Vladimir Stich, Ass Prof MD PhD principal investigator
Third Faculty of Medicine, Charles Uniersity in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric diet in people with Obesity and Insulin Resistance, run by Charles University, Czech Republic at 1 site in Czechia.
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 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 23 Feb 2007. 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 Czechia. 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?
Body weight. The study lists 2 primary outcomes in all. 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 23 Feb 2007.