Metabolic Syndrome XLEAMSNCT02696304
The Metabolic Syndrome Among Leukemia Survivors: Physiopathological Analysis
A study testing Adipose tissu repartition, Visceral and liver adipose tissue repartition and Preadipocyte quantification and adipose tissue inflamation in people with Metabolic Syndrome X, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Along with the improvement of childhood acute leukemia treatment, survival rates have increased. Therefore, the number of long term childhood leukemia survivors has increased progressively over the last decades. So, the assessment of long term health status in this population becomes very important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Adipose tissu repartition, Visceral and liver adipose tissue repartition and Preadipocyte quantification and adipose tissue inflamation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age superior or equal to 18 years
- Metabolic syndrome: at least 3 criteria among the following:
- Waist circumference ≥ 102 cm for male and ≥ 88 cm for female)
- High triglyceride level ≥ 150 mg/dl (1,7 mmol/l) or undergoing treatment for that affection
- Low HDL-Cholesterol < 40 mg/dl (1,03 mmol/l) for male ; < 50 mg/dl (1,3 mmol/l) for femal, or undergoing treatment for that affection
- Elevated blood pressure: systolic ≥ 130 mmHg and/or diastoloic ≥ 85 mmHg or undergoing treatment for that affection
Show all 9Show fewer
- Elevated fasten glucose≥ 100 mg/dl or undergoing treatment for that affection
- Acute leukemia during childhood (under 18 years of age at the time of leukemia diagnosis)
- Informed consent obtained
Who cannot join
- pregnancy
- incomplete evaluation of metabolic syndrome
Trial locations and contacts
1 site in 1 country.
Claire OUDIN, MD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Claire Oudin, claire.oudin@ap-hm.fr
Claire Oudin, MD
About this study
Official title: The Metabolic Syndrome Among Childhood Acute Leukemia Survivors: Physiopathological Analysis
Along with the improvement of childhood acute leukemia treatment, survival rates have increased. Therefore, the number of long term childhood leukemia survivors has increased progressively over the last decades. So, the assessment of long term health status in this population becomes very important. Many studies have shown an increased risk of life threatening late complications and early mortality. Cardiovascular morbidity and mortality are particularly frequent. Among these late complications, the metabolic syndrome (MS) is an important concern since it is associated with cardiovascular morbidity and mortality. The overall MS prevalence in the French prospective cohort of survivors of childhood acute leukemia was 9.2% and 18.6% in cases of total body irradiation (TBI) during the leukemia treatment. Since the median age at MS evaluation was 21 years, this prevalence was very high. Anyway, the MS pathophysiology in this population is still poorly understood. One of the most recent hypothesis about the MS mechanism is based on the adipose tissue inability to store fatty acids: when adipose tissue cannot expanse further to store excess nutriments then lipids accumulate in other tissues. This ectopic lipids accumulation can cause insulin resistance and MS.
The investigators hypothesized that the adipose tissue could be damaged by treatments received during childhood acute leukemia treatment (particularly TBI). This leads to morphological and functional abnormalities that could promote the insulin resistance and MS.
Read more
This ectopic adipose tissue contains less preadipocytes, which could impair its functional properties.
The primary endpoint of this study is to compare the morphological and functional characteristics of adipose tissue in patients with a MS who received or not TBI during childhood leukemia treatment . This comparison will focus on:
- The adipose tissue repartition and evaluation of the ectopic adipose tissue
- Fibrosis and inflammation of the adipose tissue
- Preadipocytes quantification
The secondary endpoint is to describe:
- for the whole cohort of included patients,
- the clinical and biological characteristics associated with the MS.
- Cardiovascular risk factors and nutritional statement
- Anthropometric measurements
- Detection of other endocrinal abnormalities possibly associated with the MS
- Analysis of inflammation blood markers and adipokines quantification.
Read the detailed description
Enroled patients (both groups) will be evaluated for the following criteria. Then, a comparison between both groups will be performed.
- Primary endpoint: the following factors will be studied, and compared between both groups (with or without TBI):
- Adipose tissue repartition using biphotonic absorptiometry and abdominal MRI
- Ectopic adipose tissue evaluation (visceral and hepatical) using MRI and proton spectroscopy
- Adipose tissue inflammation (using PCR array) : quantification of the following biomarkers: alpha TNF, IL6, IL1beta, IL10, MCP1, leptine and adiponectine
- Adipose tissue fibrosis (PCR array): quantification of the following markers of fibrosis: Col 1a1, Col 3a1, Col 6a1, Col 6a3, Tenascin C, Lumican, TGF beta
- Preadipocytes quantification in the adipose tissue (immunohistochemistery)
Concerning the secondary endpoints, the following points will be studied :
- Cardiovascular risk factors and nutritional statement
- Anthropometric measurements
- Other endocrinal abnormalities possibly associated with the MS
- Analysis of inflammation blood markers and adipokines quantification.
- Conditions
- Metabolic Syndrome X
- Being tested
- Adipose tissu repartition, Visceral and liver adipose tissue repartition, Preadipocyte quantification and adipose tissue inflamation, Inflamation blood markers quantification
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissu repartitionOther
absorptiometry,
Visceral and liver adipose tissue repartitionOther
MRI,spectroscopy,
Preadipocyte quantification and adipose tissue inflamationOther
biopsy
Inflamation blood markers quantificationOther
blood drawn,
| Study group | Role | What they receive |
|---|---|---|
| TBI for childhood leukemia | Other | Patients with a metabolic syndrom who received TBI. Receives: Other: Adipose tissu repartition; Other: Visceral and liver adipose tissue repartition; Other: Preadipocyte quantification and adipose tissue inflamation; Other: Inflamation blood markers quantification |
| No TBI for childhood leukemia | Other | Patients with a metabolic syndrom without previousTBI Receives: Other: Adipose tissu repartition; Other: Visceral and liver adipose tissue repartition; Other: Preadipocyte quantification and adipose tissue inflamation; Other: Inflamation blood markers quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of fat mass (Biphotonic absorptiometry)
Measured: 1 year
Evaluation of the amount of intra liver and pancreatic triglycerides (%) (proton spectroscopy, expressed as percent related to liver or pancreatic water content)
Measured: 1 year
Fibrosis and inflammation analyses of the adipose tissu : fibrosis and inflammation gene expression analyses by RQ-PCR
Measured: 1 year
Preadipocytes quantification in the adipose tissue by immunohistochemistery, expressed as percent of stroma vascular fraction of the adipose tissue
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, AP-HMClaire OUDIN, MD, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696304
- Sponsor's protocol ID
- 2015-A00170-49
- Other IDs
- 2015-05
- Acronym
- LEAMS
- Status last verified
- Dec 2015
- First submitted
- 16 Oct 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Syndrome Among Childhood Acute Leukemia Survivors: Physiopathological Analysis
- ClinicalTrials.gov ID
- NCT02696304
- Acronym / sponsor ID
- LEAMS / 2015-A00170-49
- Conditions
- Metabolic Syndrome X
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Mar 2016 (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.
Along with the improvement of childhood acute leukemia treatment, survival rates have increased. Therefore, the number of long term childhood leukemia survivors has increased progressively over the last decades. So, the assessment of long term health status in this population becomes very important. Many studies have shown an increased risk of life threatening late complications and early mortality. Cardiovascular morbidity and mortality are particularly frequent. Among these late complications, the metabolic syndrome (MS) is an important concern since it is associated with cardiovascular morbidity and mortality. The overall MS prevalence in the French prospective cohort of survivors of childhood acute leukemia was 9.2% and 18.6% in cases of total body irradiation (TBI) during the leukemia treatment. Since the median age at MS evaluation was 21 years, this prevalence was very high. Anyway, the MS pathophysiology in this population is still poorly understood. One of the most recent hypothesis about the MS mechanism is based on the adipose tissue inability to store fatty acids: when adipose tissue cannot expanse further to store excess nutriments then lipids accumulate in other tissues. This ectopic lipids accumulation can cause insulin resistance and MS.
The investigators hypothesized that the adipose tissue could be damaged by treatments received during childhood acute leukemia treatment (particularly TBI). This leads to morphological and functional abnormalities that could promote the insulin resistance and MS.
This ectopic adipose tissue contains less preadipocytes, which could impair its functional properties.
The primary endpoint of this study is to compare the morphological and functional characteristics of adipose tissue in patients with a MS who received or not TBI during childhood leukemia treatment . This comparison will focus on:
- The adipose tissue repartition and evaluation of the ectopic adipose tissue
- Fibrosis and inflammation of the adipose tissue
- Preadipocytes quantification
The secondary endpoint is to describe:
- for the whole cohort of included patients,
- the clinical and biological characteristics associated with the MS.
- Cardiovascular risk factors and nutritional statement
- Anthropometric measurements
- Detection of other endocrinal abnormalities possibly associated with the MS
- Analysis of inflammation blood markers and adipokines quantification.
Detailed description
Enroled patients (both groups) will be evaluated for the following criteria. Then, a comparison between both groups will be performed.
- Primary endpoint: the following factors will be studied, and compared between both groups (with or without TBI):
- Adipose tissue repartition using biphotonic absorptiometry and abdominal MRI
- Ectopic adipose tissue evaluation (visceral and hepatical) using MRI and proton spectroscopy
- Adipose tissue inflammation (using PCR array) : quantification of the following biomarkers: alpha TNF, IL6, IL1beta, IL10, MCP1, leptine and adiponectine
- Adipose tissue fibrosis (PCR array): quantification of the following markers of fibrosis: Col 1a1, Col 3a1, Col 6a1, Col 6a3, Tenascin C, Lumican, TGF beta
- Preadipocytes quantification in the adipose tissue (immunohistochemistery)
Concerning the secondary endpoints, the following points will be studied :
- Cardiovascular risk factors and nutritional statement
- Anthropometric measurements
- Other endocrinal abnormalities possibly associated with the MS
- Analysis of inflammation blood markers and adipokines quantification.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI for childhood leukemia | Other | Other: Adipose tissu repartition, Other: Visceral and liver adipose tissue repartition, Other: Preadipocyte quantification and adipose tissue inflamation, Other: Inflamation blood markers quantificationPatients with a metabolic syndrom who received TBI. |
| No TBI for childhood leukemia | Other | Other: Adipose tissu repartition, Other: Visceral and liver adipose tissue repartition, Other: Preadipocyte quantification and adipose tissue inflamation, Other: Inflamation blood markers quantificationPatients with a metabolic syndrom without previousTBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age superior or equal to 18 years
- Metabolic syndrome: at least 3 criteria among the following:
- Acute leukemia during childhood (under 18 years of age at the time of leukemia diagnosis)
- Informed consent obtained
Key exclusion criteria (2 listed)
- pregnancy
- incomplete evaluation of metabolic syndrome
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 |
|---|---|---|
| Adipose tissu repartitionabsorptiometry, | Other | No TBI for childhood leukemia, TBI for childhood leukemia |
| Visceral and liver adipose tissue repartitionMRI,spectroscopy, | Other | No TBI for childhood leukemia, TBI for childhood leukemia |
| Preadipocyte quantification and adipose tissue inflamationbiopsy | Other | No TBI for childhood leukemia, TBI for childhood leukemia |
| Inflamation blood markers quantificationblood drawn, | Other | No TBI for childhood leukemia, TBI for childhood leukemia |
Primary outcome
Percent of fat mass (Biphotonic absorptiometry)
Time frame: 1 year
Evaluation of the amount of intra liver and pancreatic triglycerides (%) (proton spectroscopy, expressed as percent related to liver or pancreatic water content)
Time frame: 1 year
Fibrosis and inflammation analyses of the adipose tissu : fibrosis and inflammation gene expression analyses by RQ-PCR
Time frame: 1 year
Preadipocytes quantification in the adipose tissue by immunohistochemistery, expressed as percent of stroma vascular fraction of the adipose tissue
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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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.
Claire OUDIN, MD contact
Urielle DESALBRES study director
AP-HM
Claire OUDIN, MD principal investigator
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose tissu repartition, Visceral and liver adipose tissue repartition and Preadipocyte quantification and adipose tissue inflamation in people with Metabolic Syndrome X, run by Assistance Publique Hopitaux De Marseille 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 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: status not confirmed, as of the sponsor's last update on 2 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire OUDIN, MD (claire.oudin@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of fat mass (Biphotonic absorptiometry) (time frame: 1 year). The study lists 4 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 2 Mar 2016.