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Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy

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ClinicalTrials.gov Identifier: NCT01928355
Recruitment Status : Unknown
Verified August 2013 by Assy Nimer, Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 23, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital

Brief 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. 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.


Condition or disease
Metabolic Syndrome

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Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Prospective
Study Start Date : September 2013
Estimated Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine


Group/Cohort
metabolically healthy
Unhealthy



Primary Outcome Measures :
  1. Transient elastography [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
People with greater body mass index
Criteria

Inclusion Criteria:

Freely given written informed consent BMI>=30

Exclusion Criteria:

Evidence of Chronic Liver Diseases Pregnant Women


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): NCT01928355


Contacts
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Contact: Numer Assy, MD +972-4-6828442 assy.n@ziv.health.gov.il

Sponsors and Collaborators
Ziv Hospital
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Responsible Party: Assy Nimer, Proffessor, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01928355    
Other Study ID Numbers: 0051-13-ziv
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases