Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy

NCT01928355 | Unknown

• 1 other identifier: 0051-13-ziv
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Transient elastography

  Baseline

Study Arms (2)

metabolically healthy

Unhealthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with greater body mass index

You may qualify if:

• Freely given written informed consent BMI\>=30

You may not qualify if:

• Evidence of Chronic Liver Diseases Pregnant Women

Sponsors & Collaborators

• Ziv Hospital: lead

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Numer Assy, MD

CONTACT

+972-4-6828442; assy.n@ziv.health.gov.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Last Updated: August 30, 2013

Record last verified: 2013-08