Cholinergic Status and the Metabolic Syndrome (Choliner stat)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Overweight Obese Behavioral: high complex carbohydrates diet given in a diet group Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. total soluble circulation capacity for acetylcholine hydrolysis [ Time Frame: 8 weeks or more ]

Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 8 weeks or more ]
    hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α

  2. 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.

  3. Metabolic markers [ Time Frame: 8 weeks or more ]
    Fasting Glucose, HbA1c,Insulin, lipid profile

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Prof Berliner Shlomo, Tel-Aviv Sourasky Medical Center Identifier: NCT01332708     History of Changes
Other Study ID Numbers: TASMC-11-SB-10-538-CTIL
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

Keywords provided by Tel-Aviv Sourasky Medical Center:
high complex carbohydrates
hypocaloric diet
cholinergic status

Additional relevant MeSH terms:
Metabolic Syndrome X
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs