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

August 11, 2016 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Procedure: Blood sample
Other: Obese group
Procedure: Blood sample
Other: Non-obese AD group
Non-obese AD groups
Procedure: Blood sample
Other: Obese AD group
Procedure: Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
body mass index
Time Frame: day 0
day 0
visceral fat mass level
Time Frame: day 0
day 0
leptinemia by ELISA
Time Frame: day 0
day 0
insulinemia by ELISA
Time Frame: day 0
day 0
glycemia
Time Frame: day 0
day 0
triglyceridemia
Time Frame: day 0
day 0
HDL cholesterol level in blood
Time Frame: day 0
day 0
Reactive C protein level in blood
Time Frame: day 0
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Thérèse RIVASSEAU-JONVEAUX, Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01686-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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