HypercholesterolemiaNCT03631238
The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions
An observational study of Hypercholesterolemia and Cognitive Dysfunction, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Cognitive Dysfunction, Hyperhomocysteinemia
- What is being tested?
- Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 41 participants, randomly selected from out-patient neurology and psychiatry clinics , Assiut University Hospital.
Who may be able to join
- Fifty hundred participants
- Participants are of both genders
- Aged 55 years old and over.
Who cannot join
- Patient with dementia.
- Renal and hepatic impairment.
- Parkinson's disease.
- Cerebrovascular stroke.
- Patient with chronic medical problems.
- Patients on statins.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The relationship between total serum cholesterol (TC) levels and cognition remains wily.
Some studies suggested that high TC level in old peoples is associated with a decreased risk of dementia.
Other studies have indicated that hypercholesterolemia may be a risk factor for cognitive decline and Alzheimer's disease (AD).
But a recent study published in 2014 by Cheng and colleagues, showed that, an inverse U-shaped relationship between total cholesterol level and cognitive score was found only in participants with normal homocysteine levels. Indicating that both low and high total serum cholesterol were associated with lower cognitive scores, ended to the relationship between cholesterol levels and cognitive function depends upon homocysteine levels, suggesting an interactive role between cholesterol and homocysteine on cognitive function in the elderly peoples.
The effect of high serum homocysteine (HHcy) levels on cognition was overwhelming regardless of the serum cholesterol levels but in peoples with normal homocysteine levels, both low and high cholesterol levels may be detrimental to cognitive health.
- Being tested
- Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.
- Keywords
- Cholesterol, Dementia, Homocysteine, Cognitive dysfunctions
- Medical subject headings
- Hypercholesterolemia, Cognitive Dysfunction, Hyperhomocysteinemia, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Apparently normal participants | Participants are not complaining from any cognitive decline are subjected to cognitive and cholesterol and homocysteine levels assessment. Receives: Diagnostic Test: Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start15 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MWAmeen, Assiut University
- Investigators
- Nageh F El Gamal, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631238
- Sponsor's protocol ID
- Cholesterol and cognition
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15702613Burns 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.
PubMed 21745566Cheng 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.
PubMed 25364240Ansari 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.
PubMed 25324876
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions
- ClinicalTrials.gov ID
- NCT03631238
- Acronym / sponsor ID
- Cholesterol and cognition
- Keywords
- Cholesterol, Dementia, Homocysteine, Cognitive dysfunctions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The relationship between total serum cholesterol (TC) levels and cognition remains wily.
Some studies suggested that high TC level in old peoples is associated with a decreased risk of dementia.
Other studies have indicated that hypercholesterolemia may be a risk factor for cognitive decline and Alzheimer's disease (AD).
But a recent study published in 2014 by Cheng and colleagues, showed that, an inverse U-shaped relationship between total cholesterol level and cognitive score was found only in participants with normal homocysteine levels. Indicating that both low and high total serum cholesterol were associated with lower cognitive scores, ended to the relationship between cholesterol levels and cognitive function depends upon homocysteine levels, suggesting an interactive role between cholesterol and homocysteine on cognitive function in the elderly peoples.
The effect of high serum homocysteine (HHcy) levels on cognition was overwhelming regardless of the serum cholesterol levels but in peoples with normal homocysteine levels, both low and high cholesterol levels may be detrimental to cognitive health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apparently normal participants | – | Diagnostic Test: Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.Participants are not complaining from any cognitive decline are subjected to cognitive and cholesterol and homocysteine levels assessment. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 41 participants, randomly selected from out-patient neurology and psychiatry clinics , Assiut University Hospital.
Key inclusion criteria (3 listed)
- Fifty hundred participants
- Participants are of both genders
- Aged 55 years old and over.
Key exclusion criteria (6 listed)
- Patient with dementia.
- Renal and hepatic impairment.
- Parkinson's disease.
- Cerebrovascular stroke.
- Patient with chronic medical problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.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. | Diagnostic test | Apparently normal participants |
Primary outcome
correlations between serum total cholesterol and homocysteine levels and cognitive functions
Time frame: 1 hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 15702613de 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.
- Background: PubMed 21745566Burns 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.
- Background: PubMed 25364240Cheng 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.
- Background: PubMed 25324876Ansari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nageh F El Gamal, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Cognitive Dysfunction, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlations between serum total cholesterol and homocysteine levels and cognitive functions (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631238, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.