Cholinergic Status and the Metabolic Syndrome (Choliner stat)
Recruitment status was: Not yet recruiting
|Overweight Obese||Behavioral: high complex carbohydrates diet given in a diet group|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Cholinergic Status and the Metabolic Syndrome|
- 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
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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.
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.