Hypercholesterolemia Clinical Trial
Official title:
The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions
Verified date | August 2018 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | August 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - Fifty hundred participants - Participants are of both genders - Aged 55 years old and over. Exclusion Criteria: - Patient with dementia. - Renal and hepatic impairment. - Parkinson's disease. - Cerebrovascular stroke. - Patient with chronic medical problems. - Patients on statins. |
Country | Name | City | State |
---|---|---|---|
Egypt | Michael W Ameen | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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. Review. Erratum in: J Clin Neurol. 2015 Jan;11(1):106. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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