Clinical trial NCT02868905: Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
Official title: Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Alzheimer's Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: 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
timeFrame: day 0
Secondary outcomes:
measure: body mass index
timeFrame: day 0
measure: visceral fat mass level
timeFrame: day 0
measure: leptinemia by ELISA
timeFrame: day 0
measure: insulinemia by ELISA
timeFrame: day 0
measure: glycemia
timeFrame: day 0
measure: triglyceridemia
timeFrame: day 0
measure: HDL cholesterol level in blood
timeFrame: day 0
measure: Reactive C protein level in blood
timeFrame: day 0
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy
name: Thérèse RIVASSEAU-JONVEAUX
role: PRINCIPAL_INVESTIGATOR
References: