Metabolic Syndrome X Clinical Trial
— LEAMSOfficial 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age superior or equal to 18 years - Metabolic syndrome: at least 3 criteria among the following: 1. Waist circumference = 102 cm for male and = 88 cm for female) 2. High triglyceride level = 150 mg/dl (1,7 mmol/l) or undergoing treatment for that affection 3. 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 4. Elevated blood pressure: systolic = 130 mmHg and/or diastoloic = 85 mmHg or undergoing treatment for that affection 5. 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 Exclusion Criteria: - pregnancy - incomplete evaluation of metabolic syndrome |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hopitaux de Marseille | Marseille |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of fat mass (Biphotonic absorptiometry) | 1 year | No | |
Primary | Evaluation of the amount of intra liver and pancreatic triglycerides (%) (proton spectroscopy, expressed as percent related to liver or pancreatic water content) | 1 year | No | |
Primary | Fibrosis and inflammation analyses of the adipose tissu : fibrosis and inflammation gene expression analyses by RQ-PCR | 1 year | No | |
Primary | Preadipocytes quantification in the adipose tissue by immunohistochemistery, expressed as percent of stroma vascular fraction of the adipose tissue | 1 year | No |
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