The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions

NCT03631238 | Completed

• 1 other identifier: Cholesterol and cognition
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates if the relationship between total serum cholesterol is dependent on the total serum homocysteine. Fasting blood samples will taken from participants and two batteries of cognitive scales will be used to asses any cognitive decline.

Conditions

Hypercholesterolemia; Cognitive Dysfunction; Hyperhomocysteinemia

Keywords

Cholesterol; Dementia; Homocysteine; Cognitive dysfunctions

Outcome Measures

Primary Outcomes (1)

• correlations between serum total cholesterol and homocysteine levels and cognitive functions

  Blood samples were collected after an overnight fast by using 10 mL plain tubes. Lipid profile was measured by using Cholesterol Kits and analyzed by COBAS Integra analyzer. Total cholesterol levels were measured using the sum of the LDL and HDL plus one-fifth of triglyceride levels. Samples of serum homocysteine (Hcy) are stored in specialized container at (-20◦C) temperature. Total Hcy was measured by ELISA technique, Sinogen kits and Statfax-2100 micro-plate analyzer. Cognitive functions were measured by using the Arabic version of: the 30 points Mini Mental State Exam (MMSE) and the Memory Assessment Scale (MAS) which consists of 12 subtests and the degree of 100 points. The mean of total MAS plus MMSE degrees is used (e.g., (100+30)/2=65 Points which is the maximum score). High, normal and low cholesterol level is compared to the mean of cognitive score only in participants with normal homocysteine levels (below 14 umol/l), higher levels of Hcy is excluded.

  1 hour

Study Arms (1)

Apparently normal participants

Participants are not complaining from any cognitive decline are subjected to cognitive and cholesterol and homocysteine levels assessment.

Diagnostic Test: Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.

Interventions

Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests. DIAGNOSTIC_TEST

all participant are subjected to cognitive assessment by psychometric tests by using the arabic version of Mini Mental State Exam (MMSE) and Memory Assessment Scale (MAS). Blood samples were collected in the morning using 10 mL yellow top (plain) Vacutainer tubes. Lipid profile (triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) were measured by Assiut university labs using Cholesterol Kits and analyzed by COBAS Integra analyzer. Total cholesterol levels were calculated using the sum of the LDL and HDL plus one-fifth of triglyceride levels. Samples of serum homocysteine are collected, centrifuged to separate plasma within 30 minutes after venipuncture and stored in specialized container in the Department of Clinical Pathology at (-20◦C) temperature. Total homocysteine was measured by ELISA technique, Sinogen kits (Research Use Only) and Statfax-2100 microplate analyzer.

Apparently normal participants

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included 41 participants, randomly selected from out-patient neurology and psychiatry clinics , Assiut University Hospital.

You may qualify if:

• Fifty hundred participants
• Participants are of both genders
• Aged 55 years old and over.

You may not qualify if:

• Patient with dementia.
• Renal and hepatic impairment.
• Parkinson's disease.
• Cerebrovascular stroke.
• Patient with chronic medical problems.
• Patients on statins.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Michael W Ameen

Asyut, 71111, Egypt

Location

Related Publications (4)

• de Champlain J, Wu R, Girouard H, Karas M, EL Midaoui A, Laplante MA, Wu L. Oxidative stress in hypertension. Clin Exp Hypertens. 2004 Oct-Nov;26(7-8):593-601. doi: 10.1081/ceh-200031904.

  PMID: 15702613 BACKGROUND

• Burns JM, Honea RA, Vidoni ED, Hutfles LJ, Brooks WM, Swerdlow RH. Insulin is differentially related to cognitive decline and atrophy in Alzheimer's disease and aging. Biochim Biophys Acta. 2012 Mar;1822(3):333-9. doi: 10.1016/j.bbadis.2011.06.011. Epub 2011 Jul 1.

  PMID: 21745566 BACKGROUND

• Cheng Y, Jin Y, Unverzagt FW, Su L, Yang L, Ma F, Hake AM, Kettler C, Chen C, Liu J, Bian J, Li P, Murrell JR, Hendrie HC, Gao S. The relationship between cholesterol and cognitive function is homocysteine-dependent. Clin Interv Aging. 2014 Oct 23;9:1823-9. doi: 10.2147/CIA.S64766. eCollection 2014.

  PMID: 25364240 BACKGROUND

• Ansari R, Mahta A, Mallack E, Luo JJ. Hyperhomocysteinemia and neurologic disorders: a review. J Clin Neurol. 2014 Oct;10(4):281-8. doi: 10.3988/jcn.2014.10.4.281. Epub 2014 Oct 6.

  PMID: 25324876 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

Hypercholesterolemia; Cognitive Dysfunction; Hyperhomocysteinemia; Dementia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nageh F El Gamal, MD

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 15, 2018
• Study Start: January 15, 2018
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

EG (1)