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

Obesity Clinical Trial

— Oba  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02868905
• Other study ID #: 2015-A01686-43
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 11, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Thérèse RIVASSEAU-JONVEAUX, Dr
• Email: t.jonveaux[@]chru-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Obesity

Intervention

Procedure:
• Blood sample

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		day 0	No
Secondary	body mass index		day 0	No
Secondary	visceral fat mass level		day 0	No
Secondary	leptinemia by ELISA		day 0	No
Secondary	insulinemia by ELISA		day 0	No
Secondary	glycemia		day 0	No
Secondary	triglyceridemia		day 0	No
Secondary	HDL cholesterol level in blood		day 0	No
Secondary	Reactive C protein level in blood		day 0	No