Metabolic Syndrome X Clinical Trial
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.
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.
Enroled patients (both groups) will be evaluated for the following criteria. Then, a
comparison between both groups will be performed.
1. 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.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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