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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02868905
Acronym
Oba
Enrollment
160
Registered
2016-08-16
Start date
2016-09-30
Completion date
2018-09-30
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Obesity

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.

Interventions

PROCEDUREBlood sample

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime 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 subjectsday 0

Secondary

MeasureTime frame
visceral fat mass levelday 0
leptinemia by ELISAday 0
insulinemia by ELISAday 0
body mass indexday 0
triglyceridemiaday 0
HDL cholesterol level in bloodday 0
Reactive C protein level in bloodday 0
glycemiaday 0

Countries

France

Contacts

Primary ContactThérèse RIVASSEAU-JONVEAUX, Dr
t.jonveaux@chru-nancy.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026