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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

Tracking Information
First Submitted Date August 20, 2013
First Posted Date August 23, 2013
Last Update Posted Date August 30, 2013
Study Start Date September 2013
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2013)
Transient elastography [ Time Frame: Baseline ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population People with greater body mass index
Condition Metabolic Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • metabolically healthy
  • Unhealthy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 29, 2013)
60
Original Enrollment Not Provided
Study Completion Date Not Provided
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Freely given written informed consent BMI>=30

Exclusion Criteria:

Evidence of Chronic Liver Diseases Pregnant Women

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01928355
Other Study ID Numbers 0051-13-ziv
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assy Nimer, Ziv Hospital
Study Sponsor Ziv Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Ziv Hospital
Verification Date August 2013