Cholinergic Status and the Metabolic Syndrome (Choliner stat)
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|ClinicalTrials.gov Identifier: NCT01332708|
Recruitment Status : Unknown
Verified April 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 11, 2011
Last Update Posted : April 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obese||Behavioral: high complex carbohydrates diet given in a diet group||Not Applicable|
Intervention studies have demonstrated that the autonomic disturbances of the metabolic syndrome may be reversible. A reduction in body weight induced by a hypocaloric diet exerts a marked reduction in sympathetic activity in obese people with or without metabolic syndrome. Incorporation of regular, moderate intensity aerobic exercise training during a dietary weight loss program does not confer additional benefits on resting sympathetic neural activity, compared with weight loss by diet alone. A new method has been developed to examine the sympathetic-parasympathetic status of an individual - the cholinergic status. Cholinergic Status represents the total soluble circulation capacity for acetylcholine hydrolysis. Higher cholinergic status means the individual is more sympathetic .
A cross sectional study that took place in Tel Aviv Sorasky medical center and included 632 participants found that the cholinergic status is related to metabolic syndrome parameters in a dose response manner and that it correlates significantly with glucose,HbA1c, lipid profile and hs-CRP.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cholinergic Status and the Metabolic Syndrome|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||September 2011|
Experimental: Obese and overweight subjects
The participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups.
Behavioral: high complex carbohydrates diet given in a diet group
diet groups that meet every week for eight weeks or more.
- total soluble circulation capacity for acetylcholine hydrolysis [ Time Frame: 8 weeks or more ]
- Inflammatory markers [ Time Frame: 8 weeks or more ]hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
- ROTEM - rotation thromboelastometry [ Time Frame: 8 weeks or more ]ROTEM documents the interaction of platelets with the coagulation factors from initial platelet—fibrin interaction, through platelet aggregation, clot strengthening and fibrin cross-linking to eventual clot lysis. Within 30 min, a ROTEM tracing provides information on clotting factor activity, platelet function and any clinically significant fibrinolysis.
- Metabolic markers [ Time Frame: 8 weeks or more ]Fasting Glucose, HbA1c,Insulin, lipid profile