Metabolic SyndromeNCT01928355
Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy
An observational study of Metabolic Syndrome, run by Ziv Hospital.
Trial summary
There is some evidence to suggest that obesity is a risk factor for the development of cognitive dysfunction, although this is not a universal finding. This discordance might be ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of metabolic risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2014
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with greater body mass index
Who may be able to join
- Freely given written informed consent BMI>=30
Who cannot join
- Evidence of Chronic Liver Diseases Pregnant Women
Trial locations and contacts
No sites are listed yet.
About this study
There is some evidence to suggest that obesity is a risk factor for the development of cognitive dysfunction, although this is not a universal finding. This discordance might be ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of metabolic risk factors. We examined whether the association of obesity with cognitive dysfunction is dependent on the individual's metabolic health.
60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol, triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as 'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results: Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized as metabolically healthy. Relative to non-obese healthy participants, after adjustment for baseline covariates, the metabolically unhealthy obese participants had elevated risk of cognitive dysfunction although the metabolically healthy obese did not. The association between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic health, although further work is required to confirm these findings.
In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese patients suffer from higher incidences of cardiovascular complications such as atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are three different types of Hp which differ in their antioxidant ability. Several clinical studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular diseases.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metabolically healthy | Not described | |
| Unhealthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transient elastography
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assy Nimer, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928355
- Sponsor's protocol ID
- 0051-13-ziv
- Status last verified
- Aug 2013
- First submitted
- 20 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy
- ClinicalTrials.gov ID
- NCT01928355
- Acronym / sponsor ID
- 0051-13-ziv
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (estimated)
- First posted
- 23 Aug 2013 (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.
There is some evidence to suggest that obesity is a risk factor for the development of cognitive dysfunction, although this is not a universal finding. This discordance might be ascribed to the existence of a 'healthy obese phenotype'- that is, obesity in the absence of metabolic risk factors. We examined whether the association of obesity with cognitive dysfunction is dependent on the individual's metabolic health.
60 obese patients' undergoping liver fibroscan and blood tests will be enrolled. Obesity was defined as body mass index ≥ 30 kg/m2. Based on blood pressure, HDL-cholesterol, triglycerides, glycated haemoglobin, and C-reactive protein, participants were classified as 'metabolically healthy' (0 or 1 metabolic abnormality) or 'unhealthy' (≥ 2 metabolic abnormalities). Cognitive dysfunction will be assessed by moca and minimental score. Results: Cognitive dysfunction prevalence is expected in 30% , but 50% of this group was categorized as metabolically healthy. Relative to non-obese healthy participants, after adjustment for baseline covariates, the metabolically unhealthy obese participants had elevated risk of cognitive dysfunction although the metabolically healthy obese did not. The association between obesity and risk of cognitive dysfunction appears to be partly dependent on metabolic health, although further work is required to confirm these findings.
In obesity there is an increase in oxidative stress due to metabolic syndrome . Thus obese patients suffer from higher incidences of cardiovascular complications such as atherosclerosis as compare to non- obese population. Haptoglobin (Hp) is a plasma protein which binds free hemoglobin and prevents it from heme- iron mediated oxidation. There are three different types of Hp which differ in their antioxidant ability. Several clinical studies have shown that Hp 2-2 genotype is associated with higher incidence of cardiovascular diseases.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metabolically healthy | – | – |
| Unhealthy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with greater body mass index
Key inclusion criteria (1 listed)
- Freely given written informed consent BMI>=30
Key exclusion criteria (1 listed)
- Evidence of Chronic Liver Diseases Pregnant Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transient elastography
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Ziv Hospital.
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 1 inclusion and 1 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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 Numer Assy, MD (+972-4-6828442, assy.n@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transient elastography (time frame: Baseline). 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 30 Aug 2013.