NCT02868905

Brief Summary

The purpose of this study is to compare average methylation of epigenetic markers on genomic DNA and some genes (APP, BACE, LRP, SorL1) involved in cerebral amyloid homeostasis:

  • Of obese young adults and healthy young adults
  • Of obese young adults and individuals affected by Alzheimer's disease (AD) having been obese at young adult age (\<50 years old) or individuals affected by Alzheimer's disease (AD) having never been obese. The secondary purpose is to determine if there is an association between the frequency of these epigenetic markers and elements associated to the metabolic syndrome (lipidic and glycemic analysis, leptinemia, inflammation markers) and clinical ones (visceral fat mass, body mass index) in young adults.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 11, 2016

Last Update Submit

August 11, 2016

Conditions

ObesityAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Methylation of CpG islands in genomic DNA and in 4 target genes involved in AD (APP, SorLA/LR11, BACE1, LRP) in obese and AD subjects

    day 0

Secondary Outcomes (8)

  • body mass index

    day 0

  • visceral fat mass level

    day 0

  • leptinemia by ELISA

    day 0

  • insulinemia by ELISA

    day 0

  • glycemia

    day 0

  • +3 more secondary outcomes

Study Arms (4)

Control group

OTHER

Control group

Procedure: Blood sample

Obese group

OTHER

Obese group

Procedure: Blood sample

Non-obese AD group

OTHER

Non-obese AD groups

Procedure: Blood sample

Obese AD group

OTHER

Obese AD group

Procedure: Blood sample

Interventions

Blood samplePROCEDURE
Control groupNon-obese AD groupObese AD groupObese group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group 1:
  • year old women, age- (10 years) and sociocultural-matched with group 2
  • Non obese and never been obese
  • \< BMI \< 25
  • Folstein MMS \> 27
  • Informed consent
  • Affiliation to social security plan
  • Group 2:
  • year old women, age- (10 years) and sociocultural-matched with group 1
  • Waist size \> 88cm
  • \< BMI \< 45
  • Insulin-resistant patients (Insulin resistance index, HOMA-IR \> 3.8)
  • Obesity onset during childhood (pre-puberty period)
  • Folstein MMS \> 27
  • Informed consent
  • +15 more criteria

You may not qualify if:

  • Group 1:
  • \<18
  • Patient under guardianship, curatorship or judicial protection
  • Folate supplementation
  • Diabetic or glucose intolerant subjects
  • Present participation to another study with neuropsychological evaluation and/or drug administration
  • Pregnant women
  • Groups 2,3 and 4:
  • \<18
  • Patient under guardianship, curatorship or judicial protection
  • Folate supplementation
  • Present participation to another study with neuropsychological evaluation and/or drug administration
  • Group 2:
  • \- Pregnant women
  • Group 4:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, France

Location

MeSH Terms

Conditions

ObesityAlzheimer Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Thérèse RIVASSEAU-JONVEAUX

    Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thérèse RIVASSEAU-JONVEAUX, Dr

CONTACT

t.jonveaux@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

FR(1)