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Cholinergic Status and the Metabolic Syndrome (Choliner stat)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01332708
First received: April 7, 2011
Last updated: April 8, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Overweight
Obese
 Behavioral: high complex carbohydrates diet given in a diet group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cholinergic Status and the Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • total soluble circulation capacity for acetylcholine hydrolysis [ Time Frame: 8 weeks or more ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 8 weeks or more ] [ Designated as safety issue: No ]
    hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α

  • ROTEM - rotation thromboelastometry [ Time Frame: 8 weeks or more ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fasting Glucose, HbA1c,Insulin, lipid profile


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof Berliner Shlomo, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01332708     History of Changes
Other Study ID Numbers: TASMC-11-SB-10-538-CTIL
Study First Received: April 7, 2011
Last Updated: April 8, 2011
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 19, 2013