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

Primary Purpose

Obesity, Alzheimer's Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sample

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

CHRU de Nancy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Control group

Obese group

Non-obese AD group

Obese AD group

Arm Description

Control group

Obese group

Non-obese AD groups

Obese AD group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

body mass index

visceral fat mass level

leptinemia by ELISA

insulinemia by ELISA

glycemia

triglyceridemia

HDL cholesterol level in blood

Reactive C protein level in blood

Full Information

NCT ID

NCT02868905

First Posted

August 11, 2016

Last Updated

August 11, 2016

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT02868905

Brief Title

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

Acronym

Oba

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Alzheimer's Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Other

Arm Description

Control group

Arm Title

Obese group

Arm Type

Other

Arm Description

Obese group

Arm Title

Non-obese AD group

Arm Type

Other

Arm Description

Non-obese AD groups

Arm Title

Obese AD group

Arm Type

Other

Arm Description

Obese AD group

Intervention Type

Procedure

Intervention Name(s)

Blood sample

Primary Outcome Measure Information:

Title

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

Time Frame

day 0

Secondary Outcome Measure Information:

Title

body mass index

Time Frame

day 0

Title

visceral fat mass level

Time Frame

day 0

Title

leptinemia by ELISA

Time Frame

day 0

Title

insulinemia by ELISA

Time Frame

day 0

Title

glycemia

Time Frame

day 0

Title

triglyceridemia

Time Frame

day 0

Title

HDL cholesterol level in blood

Time Frame

day 0

Title

Reactive C protein level in blood

Time Frame

day 0

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thérèse RIVASSEAU-JONVEAUX, Dr

t.jonveaux@chru-nancy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thérèse RIVASSEAU-JONVEAUX

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU de Nancy

City

Nancy

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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