Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia

Hypobetalipoproteinemia Clinical Trial

— HYPOPSY  

Official title:

Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889614
• Other study ID #: RC15_0345
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: July 11, 2017
• Start date: May 2015
• Est. completion date: July 31, 2015

Study information

• Verified date: July 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

Description:

Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism (Low Density Lipoprotein - Cholesterol) whose incidence is measured from 1: 500 to 1: 1000. These heterozygous individuals may be asymptomatic or present some clinical (fatty liver, diabetes) or psychiatric manifestations still unrecognized. Moreover, these individuals have mostly a longevity syndrome and cardiovascular protection. The FHBL is often due to mutations of the APOB (APOlipoprotein B), major component of LDL, VLDL (Very Low Density Lipoprotein) and chylomicrons, and in some cases, loss-of-function mutations of the serine protease PCSK9, endogenous inhibitor of the LDL receptor.

HYPOPSY research, aims to evaluate, in a population with psychiatric disorders, the prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 31, 2015
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients admitted in mental Disorders Unit in Nantes University Hospital

Exclusion Criteria:

• Minor patient

Related Conditions & MeSH terms

• Hypobetalipoproteinemia
• Hypobetalipoproteinemias
• Mental Disorders

Intervention

Other:
• Hypobetalipoproteinemia diagnosis (LDL-C = 50 mg/dL without hypolipidemic treatment)
LDL-C dosage.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hypobetalipoproteinemia (LDL-C = 50 mg/dL without hypolipidemic treatment) among psychiatric patients managed in Nantes University Hospital	Dosage of LDL-C	Inclusion.