Cholinergic Status and the Metabolic Syndrome

Study Overview
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Brief Summary
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The investigators aims in the current study are to examine whether the cholinergic status should be considered as another risk factor for the metabolic syndrome and it's co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the cholinergic status of overweight and obese adults with and without the metabolic syndrome.

Detailed Description
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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.

Official Title
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Cholinergic Status and the Metabolic Syndrome

Conditions
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Overweight, Obese

Intervention / Treatment
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* Behavioral: high complex carbohydrates diet given in a diet group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 25kg/m2 Stable weight (±1kg)in the previous six months Non smokers Exclusion Criteria: Type II diabetes Hypertension pharmacologically treated Cardiovascular disease Renal disease Cirrhosis and end-stage liver failure Thyroid disease Cerebrovascular disease Cancer Autoimmune disease Chronic inflammatory disease Surgery or heart catheterization in the previous six months Use of drugs known to affect measured parameters

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese and overweight subjects<br>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<br>* diet groups that meet every week for eight weeks or more.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total soluble circulation capacity for acetylcholine hydrolysis |  | 8 weeks or more | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α | 8 weeks or more | 
| ROTEM - rotation thromboelastometry | 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. | 8 weeks or more | 
| Metabolic markers | Fasting Glucose, HbA1c,Insulin, lipid profile | 8 weeks or more | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high complex carbohydrates, hypocaloric diet, cholinergic status, overweight, obese