Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women

NCT ID: NCT02868905

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control group

Control group

Group Type OTHER

Blood sample

Intervention Type PROCEDURE

Obese group

Obese group

Group Type OTHER

Blood sample

Intervention Type PROCEDURE

Non-obese AD group

Non-obese AD groups

Group Type OTHER

Blood sample

Intervention Type PROCEDURE

Obese AD group

Obese AD group

Group Type OTHER

Blood sample

Intervention Type PROCEDURE

Interventions

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Blood sample

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Group 1:

* 18-50 year old women, age- (10 years) and sociocultural-matched with group 2
* Non obese and never been obese
* 18.5 \< BMI \< 25
* Folstein MMS \> 27
* Informed consent
* Affiliation to social security plan

Group 2:

* 18-50 year old women, age- (10 years) and sociocultural-matched with group 1
* Waist size \> 88cm
* 30 \< BMI \< 45
* Insulin-resistant patients (Insulin resistance index, HOMA-IR \> 3.8)
* Obesity onset during childhood (pre-puberty period)
* Folstein MMS \> 27
* Informed consent
* Affiliation to social security plan

Group 3:

* \>60 year old women, age- (10 years) matched with group 4
* No obesity history (18.5 ≤ BMI \< 25 at adult age)
* Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease
* 15\< Folstein MMS ≤ 26
* Informed consent
* Affiliation to social security plan

Group 4:

* \>60 year old women, age- (10 years) matched with group 3
* Obesity history (BMI \> 30 at least one time at adult age)
* Sporadic forms of mild to moderate AD with demonstration of AD physiopathologic process according to new recommendations of 2011 of National Institute on Aging and Alzheimer's Association on diagnostic guidelines for Alzheimer's disease
* 15 \< Folstein MMS ≤ 26
* Informed consent
* Affiliation to social security plan

Exclusion Criteria

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:

\- Obese or overweight patients (BMI\>25)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thérèse RIVASSEAU-JONVEAUX

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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CHRU de Nancy

Nancy, , France

Site Status

Countries

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France

Central Contacts

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Thérèse RIVASSEAU-JONVEAUX, Dr

Role: CONTACT

Other Identifiers

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2015-A01686-43

Identifier Type: -

Identifier Source: org_study_id

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