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Report for Clinical Trial NCT01146132

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Nutrition and Physical Activity in Patients With Cerebrovascular Disease

The study will provide evidence of eating habits and physical activity in cerebrovascular patients in Luxembourg and of the degree to which these habits may be changed acutely (after one month) and in the long run (after 4 months) by intensive counselling. Furthermore the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition, and on surrogate parameters for stroke will be assessed.

NCT01146132 Cerebrovascular Disorders
MeSH: Cerebrovascular Disorders

2 Interventions

Name: Conventional diet +/- wine

Description: usual eating habits

Type: Dietary Supplement

conventional conventional + wine

Name: Luxembourg variant of Mediterranean diet + physical activity +/- wine

Description: Walnuts, almonds, mustard and soy bean products as part of the Indo-Mediterranean diet could be recommended to ensure a variety of food constellation, as well as dark chocolate. This form of diet will be addressed to as "Luxembourg variant of the Mediterranean diet"

Type: Dietary Supplement

Luxembourg diet Luxembourg diet + wine


Primary Outcomes

Description: Assess the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition and on surrogate parameters for cerebrovascular disease.

Measure: Differences in mean systolic blood pressure in the two diet/sport arms

Time: 4 months

Secondary Outcomes

Description: Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.

Measure: Effects on cerebrovascular health profile

Time: 4 months

Description: The genetic analyses will investigate: A) Profiles of inflammatory, anti-inflammatory cytokines B) Genes related to risk of stroke C) Chromosome regions related to atherosclerosis D) Genetic polymorphism in inflammation Genes to be analyzed: FABP2, MTP1, ApoE, ApoA1, PPAR gamma Pro 12 Ala, TNF alpha, Paraoxonase 1, ADH, Kinesin-like protein (KIF) 6 Trp719Arg (rs20455), SNP, 5 (component of complement 5) 2416A> G variant (rs17611), sCAMs (sICAM-1, sVCAM-1, sPSEL et sESEL), (C3, C4) Complement and CRP, P-selectin and its ligand, P-selectin glycoprotein ligand 1

Measure: Assessment of genetic marker and/or genetic modifications.

Time: Baseline

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 rs17611

The genetic analyses will investigate: A) Profiles of inflammatory, anti-inflammatory cytokines B) Genes related to risk of stroke C) Chromosome regions related to atherosclerosis D) Genetic polymorphism in inflammation Genes to be analyzed: FABP2, MTP1, ApoE, ApoA1, PPAR gamma Pro 12 Ala, TNF alpha, Paraoxonase 1, ADH, Kinesin-like protein (KIF) 6 Trp719Arg (rs20455), SNP, 5 (component of complement 5) 2416A> G variant (rs17611), sCAMs (sICAM-1, sVCAM-1, sPSEL et sESEL), (C3, C4) Complement and CRP, P-selectin and its ligand, P-selectin glycoprotein ligand 1. Inclusion Criteria: - In- and outpatients of the Neurology Department of the CHL and their family members - Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction - No acute stroke/TIA/amaurosis fugax (at least 3 months ago) - Temporal ultrasound window suitable for recording of the middle cerebral artery - Ability to give informed consent Exclusion Criteria: - No signed informed consent - patient not able to give informed consent Inclusion Criteria: - In- and outpatients of the Neurology Department of the CHL and their family members - Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction - No acute stroke/TIA/amaurosis fugax (at least 3 months ago) - Temporal ultrasound window suitable for recording of the middle cerebral artery - Ability to give informed consent Exclusion Criteria: - No signed informed consent - patient not able to give informed consent Cerebrovascular Disorders Cerebrovascular Disorders Quality of life in the elderly and their families is severely affected by stroke and cognitive dysfunction caused by atherosclerosis of the brain supplying arteries.


2 rs20455

The genetic analyses will investigate: A) Profiles of inflammatory, anti-inflammatory cytokines B) Genes related to risk of stroke C) Chromosome regions related to atherosclerosis D) Genetic polymorphism in inflammation Genes to be analyzed: FABP2, MTP1, ApoE, ApoA1, PPAR gamma Pro 12 Ala, TNF alpha, Paraoxonase 1, ADH, Kinesin-like protein (KIF) 6 Trp719Arg (rs20455), SNP, 5 (component of complement 5) 2416A> G variant (rs17611), sCAMs (sICAM-1, sVCAM-1, sPSEL et sESEL), (C3, C4) Complement and CRP, P-selectin and its ligand, P-selectin glycoprotein ligand 1. Inclusion Criteria: - In- and outpatients of the Neurology Department of the CHL and their family members - Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction - No acute stroke/TIA/amaurosis fugax (at least 3 months ago) - Temporal ultrasound window suitable for recording of the middle cerebral artery - Ability to give informed consent Exclusion Criteria: - No signed informed consent - patient not able to give informed consent Inclusion Criteria: - In- and outpatients of the Neurology Department of the CHL and their family members - Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction - No acute stroke/TIA/amaurosis fugax (at least 3 months ago) - Temporal ultrasound window suitable for recording of the middle cerebral artery - Ability to give informed consent Exclusion Criteria: - No signed informed consent - patient not able to give informed consent Cerebrovascular Disorders Cerebrovascular Disorders Quality of life in the elderly and their families is severely affected by stroke and cognitive dysfunction caused by atherosclerosis of the brain supplying arteries.



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