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Clinical Trials/NCT01928355
NCT01928355
Unknown
Not Applicable

Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy

Ziv Hospital0 sites60 target enrollmentStarted: September 2013Last updated:

Overview

Phase
Not Applicable
Sponsor
Ziv Hospital
Enrollment
60
Primary Endpoint
Transient elastography

Overview

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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Freely given written informed consent BMI\>=30

Exclusion Criteria

  • Evidence of Chronic Liver Diseases Pregnant Women

Outcomes

Primary Outcomes

Transient elastography

Time Frame: Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ziv Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Assy Nimer

Proffessor

Ziv Hospital

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