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Trial record 49 of 96 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

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
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. 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.

Condition or disease Intervention/treatment Phase
Familial Hypobetalipoproteinemia Diagnostic Test: Psychiatric population Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1822 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients hospitalized in one of the full-time adult psychiatric departments of Nantes University Hospital may be included, without maximum age limit.

Minors and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study

Exclusion Criteria:

  • minors under 15 years
  • pregnant or nursing woman;
  • simultaneous participation in another interventional research on a drug;
  • not mastering the reading and writing of the French language well enough

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549637


Contacts
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Contact: Marie GRALL-BRONNEC, Pr 02.40.84.76.20 marie.bronnec@chu-nantes.fr
Contact: Gaëlle CHALLET 02.40.84.76.20 gaelle.bouju@chu-nantes.fr

Locations
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France
Nantes University Hospital Nantes Recruiting
Nantes, France, 44000
Contact: Marie GRALL-BRONNEC, Pr    02.40.84.76.20    marie.bronnec@chu-nantes.fr   
Contact: Gaëlle CHALLET    02.40.84.76.20    gaelle.bouju@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Marie GRALL-BRONNEC, Pr Nantes University Hospital Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03549637     History of Changes
Other Study ID Numbers: RC17_0468
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Psychiatry, hypobetalipoproteinemia, LDL-Cholesterol
Additional relevant MeSH terms:
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Hypobetalipoproteinemias
Hypobetalipoproteinemia, Familial, Apolipoprotein B
Hypolipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases