Cholinergic Status and the Metabolic Syndrome

Not Applicable

• Conditions: Obese; Overweight
• Interventions: Behavioral: high complex carbohydrates diet given in a diet group

• Registration Number: NCT01332708
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Last Update Submitted: 2011-04-08
• Study First Posted: 2011-04-11
• Last Update Posted: 2011-04-11
• Primary Completion: 2011-08
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obese and overweight subjects	high complex carbohydrates diet given in a diet group	The participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups.

Primary Outcome Measures

Name	Time	Method
total soluble circulation capacity for acetylcholine hydrolysis	8 weeks or more

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	8 weeks or more	hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
ROTEM - rotation thromboelastometry	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	8 weeks or more	Fasting Glucose, HbA1c,Insulin, lipid profile