The Metabolic Syndrome Among Leukemia Survivors: Physiopathological Analysis
LEAMS
The Metabolic Syndrome Among Childhood Acute Leukemia Survivors: Physiopathological Analysis
2 other identifiers
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 2, 2016
December 1, 2015
1 year
October 16, 2015
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Percent of fat mass (Biphotonic absorptiometry)
1 year
Evaluation of the amount of intra liver and pancreatic triglycerides (%) (proton spectroscopy, expressed as percent related to liver or pancreatic water content)
1 year
Fibrosis and inflammation analyses of the adipose tissu : fibrosis and inflammation gene expression analyses by RQ-PCR
1 year
Preadipocytes quantification in the adipose tissue by immunohistochemistery, expressed as percent of stroma vascular fraction of the adipose tissue
1 year
Study Arms (2)
TBI for childhood leukemia
OTHERPatients with a metabolic syndrom who received TBI.
No TBI for childhood leukemia
OTHERPatients with a metabolic syndrom without previousTBI
Interventions
absorptiometry,
MRI,spectroscopy,
biopsy
blood drawn,
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- pregnancy
- incomplete evaluation of metabolic syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urielle DESALBRES
AP-HM
- PRINCIPAL INVESTIGATOR
Claire OUDIN, MD
AP-HM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2015
First Posted
March 2, 2016
Study Start
May 1, 2015
Primary Completion
May 1, 2016
Study Completion
December 1, 2016
Last Updated
March 2, 2016
Record last verified: 2015-12