ObesityNCT01644942
Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation
A study testing Lipid accumulation analysis in people with Obesity and Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Obesity, Insulin Resistance, Hyperlipidemia
- What is being tested?
- Lipid accumulation analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Jun 2013
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients with a Body Mass Index (BMI) between 30 and 40 kg/m2
- Patients who do not practice physical exercise (Voorips index < 9)
- Age between 40 and 70 years- Male gender
- Fast blood glucose <1,10 g/l and no hypoglycemic treatment
- Signed informed consent
- Social security affiliation
Show all 9Show fewer
- Absence of anti VIH, anti hepatitis C antibodies, and HBS antigen
- Normal biological tests
- Non smoking persons
Who cannot join
- Patients who refuse the anti-VIH, anti-hepatitis C antibodies, and HBS antigens tests
- Patients treated by anticoagulant, b blockers, lipopenic, or anti-inflammatory.
- Patients with a contraindication to muscular exercise (retinopathy, coronaropathy, nephropathy) and to muscular biopsy
- Allergy to local anaesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.
The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.
Read the detailed description
Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance test, indirect calorimetry during exercise and muscular biopsy.
- Conditions
- Obesity, Insulin Resistance, Hyperlipidemia
- Being tested
- Lipid accumulation analysis
- Keywords
- Obese, insulin sensitive, insulin resistant, myotubes, lipid accumulation
- Medical subject headings
- Obesity, Insulin Resistance, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid accumulation analysisOther
The lipid accumulation will be assessed with muscular biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Insulin sensitive patients | Other | Not described Receives: Other: Lipid accumulation analysis |
| Insulin resistant patients | Other | Not described Receives: Other: Lipid accumulation analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid accumulation in skeletal muscle
Measured: 1 month
Secondary outcomes (1)
lipid accumulation in myotubes from obese patients
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startMay 2008
- Primary completionJun 2013
- Study completionJun 2013
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 University Hospital, MontpellierThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644942
- Sponsor's protocol ID
- 8193
- Status last verified
- Jun 2013
- First submitted
- 17 Jul 2012
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.
- ClinicalTrials.gov ID
- NCT01644942
- Acronym / sponsor ID
- 8193
- Conditions
- Obesity, Insulin Resistance, Hyperlipidemia
- Keywords
- Obese, insulin sensitive, insulin resistant, myotubes, lipid accumulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Jul 2012 (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 study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.
Detailed description
Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance test, indirect calorimetry during exercise and muscular biopsy.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin sensitive patients | Other | Other: Lipid accumulation analysis |
| Insulin resistant patients | Other | Other: Lipid accumulation analysis |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Obese patients with a Body Mass Index (BMI) between 30 and 40 kg/m2
- Patients who do not practice physical exercise (Voorips index < 9)
- Age between 40 and 70 years- Male gender
- Fast blood glucose <1,10 g/l and no hypoglycemic treatment
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients who refuse the anti-VIH, anti-hepatitis C antibodies, and HBS antigens tests
- Patients treated by anticoagulant, b blockers, lipopenic, or anti-inflammatory.
- Patients with a contraindication to muscular exercise (retinopathy, coronaropathy, nephropathy) and to muscular biopsy
- Allergy to local anaesthetic
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 |
|---|---|---|
| Lipid accumulation analysisThe lipid accumulation will be assessed with muscular biopsies. | Other | Insulin resistant patients, Insulin sensitive patients |
Primary outcome
lipid accumulation in skeletal muscle
Time frame: 1 month
1 secondary outcome
lipid accumulation in myotubes from obese patients
Time frame: 1 month
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 18 Jun 2013.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid accumulation analysis in people with Obesity and Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
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 9 inclusion and 4 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 18 Jun 2013. 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 France. 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?
lipid accumulation in skeletal muscle (time frame: 1 month). 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 18 Jun 2013.