An interventional study of Adipose tissu repartition and Visceral and liver adipose tissue repartition in Metabolic Syndrome X, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-02.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic
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 secondary endpoint is to describe:
Enroled patients (both groups) will be evaluated for the following criteria. Then, a comparison between both groups will be performed.
Concerning the secondary endpoints, the following points will be studied :
1,963 studies on the registry are indexed under Metabolic Syndrome; 329 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 1,459 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
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Metabolic syndrome: at least 3 criteria among the following:
Exclusion Criteria:
Patients with a metabolic syndrom who received TBI.
Other: Adipose tissu repartition · Other: Visceral and liver adipose tissue repartition · Other: Preadipocyte quantification and adipose tissue inflamation · Other: Inflamation blood markers quantification
Patients with a metabolic syndrom without previousTBI
Other: Adipose tissu repartition · Other: Visceral and liver adipose tissue repartition · Other: Preadipocyte quantification and adipose tissue inflamation · Other: Inflamation blood markers quantification
absorptiometry,
MRI,spectroscopy,
biopsy
blood drawn,
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
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille