Informations générales (source: ClinicalTrials.gov)
The Metabolic Syndrome Among Childhood Acute Leukemia Survivors: Physiopathological Analysis (LEAMS)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
mai 2015
décembre 2016
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | Claire Oudin | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- pregnancy
- incomplete evaluation of metabolic syndrome