Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)
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|ClinicalTrials.gov Identifier: NCT03549637|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Familial Hypobetalipoproteinemia||Diagnostic Test: Psychiatric population||Not Applicable|
Some forms of hypobetalipoproteinemia (HBL) are associated with a longevity syndrome and cardiovascular protection due to prolonged exposure to low levels of LDL-C. However, while LDL-C reduction has been studied extensively for its beneficial effect on cardiovascular risk, other studies have reported that low levels of LDL-C (either spontaneous or artificially occurring with low-fat diets or lipid-lowering drugs) may be associated with psychiatric symptoms (psychotic or mood disorders, aggression, suicidal attempts, etc.) or altered cognitive performance (particularly executive functioning). These studies have led to contradictory results, and the possible link between low LDL-C levels and psychiatric symptoms remains highly controversial so far.
The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population. Moreover, the study includes the characterization of psychiatric disorders as well as psychological and personal characteristics associated with HBL. The evolutionary profile of patients with and without HBL will be studied. Genetic characteristics and biomarkers of HBL will also be studied.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1822 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||February 22, 2020|
|Estimated Study Completion Date :||August 22, 2020|
Experimental: Psychiatric population
At inclusion: Patients will have A Lipid Panel Test, other biological analyzes and a clinical assessment. In case of a low LDL-C level (≤ 0, 50 g/L), genetic analyzes will be performed to screen for genetic forms of hypobetalipoproteinemia (HBL).
At 2- 4 weeks: for patients with HBL (LDL-C ≤ 0,50 g/L with no secondary cause of LDL-C reduction), another Lipid Panel Test will be performed to confirm the maintenance of the low LDL-C level.
At 6 months : Patients with a HBL will perform a full biological examination, and the LDL-C levels and genetic analyzes will be confirmed. A dietary survey will be performed, together with a psychiatric assessment. The same numbers of matched controls will performed a quick telephone interview to collect the psychiatric characteristics.
Diagnostic Test: Psychiatric population
Genetic and biological analysis of patients
- Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C [ Time Frame: at baseline (admission at the hospital) ]LDL-C level < 0,50 g/L
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549637
|Contact: Marie GRALL-BRONNEC, Prfirstname.lastname@example.org|
|Contact: Gaëlle CHALLETemail@example.com|
|Nantes University Hospital Nantes||Recruiting|
|Nantes, France, 44000|
|Contact: Marie GRALL-BRONNEC, Pr 02.40.84.76.20 firstname.lastname@example.org|
|Contact: Gaëlle CHALLET 02.40.84.76.20 email@example.com|
|Principal Investigator:||Marie GRALL-BRONNEC, Pr||Nantes University Hospital Nantes|