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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02868905
Recruitment Status : Unknown
Verified August 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Obesity Alzheimer's Disease Procedure: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women - Pilot Study
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control group
Control group
Procedure: Blood sample
Obese group
Obese group
Procedure: Blood sample
Non-obese AD group
Non-obese AD groups
Procedure: Blood sample
Obese AD group
Obese AD group
Procedure: Blood sample



Primary Outcome Measures :
  1. 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 Measures :
  1. body mass index [ Time Frame: day 0 ]
  2. visceral fat mass level [ Time Frame: day 0 ]
  3. leptinemia by ELISA [ Time Frame: day 0 ]
  4. insulinemia by ELISA [ Time Frame: day 0 ]
  5. glycemia [ Time Frame: day 0 ]
  6. triglyceridemia [ Time Frame: day 0 ]
  7. HDL cholesterol level in blood [ Time Frame: day 0 ]
  8. Reactive C protein level in blood [ Time Frame: day 0 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868905


Contacts
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Contact: Thérèse RIVASSEAU-JONVEAUX, Dr t.jonveaux@chru-nancy.fr

Locations
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France
CHRU de Nancy
Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Thérèse RIVASSEAU-JONVEAUX Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02868905    
Other Study ID Numbers: 2015-A01686-43
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Alzheimer Disease
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders