ObesityObaNCT02868905
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
A study testing Blood sample in people with Obesity and Alzheimer's Disease, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Alzheimer's Disease
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Thérèse RIVASSEAU-JONVEAUX, Dr contact
About this study
Official title: 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.
- Conditions
- Obesity, Alzheimer's Disease
- Being tested
- Blood sample
- Medical subject headings
- Obesity, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control group Receives: Procedure: Blood sample |
| Obese group | Other | Obese group Receives: Procedure: Blood sample |
| Non-obese AD group | Other | Non-obese AD groups Receives: Procedure: Blood sample |
| Obese AD group | Other | Obese AD group Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 0
Secondary outcomes (8)
body mass index
Measured: day 0
visceral fat mass level
Measured: day 0
leptinemia by ELISA
Measured: day 0
insulinemia by ELISA
Measured: day 0
glycemia
Measured: day 0
triglyceridemia
Measured: day 0
HDL cholesterol level in blood
Measured: day 0
Reactive C protein level in blood
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thérèse RIVASSEAU-JONVEAUX, Principal investigator, Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868905
- Sponsor's protocol ID
- 2015-A01686-43
- Acronym
- Oba
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women - Pilot Study
- ClinicalTrials.gov ID
- NCT02868905
- Acronym / sponsor ID
- Oba / 2015-A01686-43
- Conditions
- Obesity, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: Blood sampleControl group |
| Obese group | Other | Procedure: Blood sampleObese group |
| Non-obese AD group | Other | Procedure: Blood sampleNon-obese AD groups |
| Obese AD group | Other | Procedure: Blood sampleObese AD group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (16 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample | Procedure or surgery | Control group, Non-obese AD group, Obese AD group, Obese group |
Primary outcome
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
8 secondary outcomes
body mass index
Time frame: day 0
visceral fat mass level
Time frame: day 0
leptinemia by ELISA
Time frame: day 0
insulinemia by ELISA
Time frame: day 0
glycemia
Time frame: day 0
triglyceridemia
Time frame: day 0
HDL cholesterol level in blood
Time frame: day 0
Reactive C protein level in blood
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thérèse RIVASSEAU-JONVEAUX, Dr contact
Thérèse RIVASSEAU-JONVEAUX principal investigator
Service de Gériatrie, Hôpitaux de Brabois, 3 rue du Morvan, 54 511 Vandoeuvre-lès-Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Obesity and Alzheimer's Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thérèse RIVASSEAU-JONVEAUX, Dr (t.jonveaux@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.