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Cholinergic Status and the Metabolic Syndrome (Choliner stat)

Primary Purpose

Overweight, Obese

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high complex carbohydrates diet given in a diet group
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring high complex carbohydrates, hypocaloric diet, cholinergic status, overweight, obese

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Obese and overweight subjects

    Arm Description

    The participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups.

    Outcomes

    Primary Outcome Measures

    total soluble circulation capacity for acetylcholine hydrolysis

    Secondary Outcome Measures

    Inflammatory markers
    hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
    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.
    Metabolic markers
    Fasting Glucose, HbA1c,Insulin, lipid profile

    Full Information

    First Posted
    April 7, 2011
    Last Updated
    April 8, 2011
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01332708
    Brief Title
    Cholinergic Status and the Metabolic Syndrome
    Acronym
    Choliner stat
    Official Title
    Cholinergic Status and the Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    August 2011 (Anticipated)
    Study Completion Date
    September 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Obese
    Keywords
    high complex carbohydrates, hypocaloric diet, cholinergic status, overweight, obese

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Obese and overweight subjects
    Arm Type
    Experimental
    Arm Description
    The participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups.
    Intervention Type
    Behavioral
    Intervention Name(s)
    high complex carbohydrates diet given in a diet group
    Intervention Description
    diet groups that meet every week for eight weeks or more.
    Primary Outcome Measure Information:
    Title
    total soluble circulation capacity for acetylcholine hydrolysis
    Time Frame
    8 weeks or more
    Secondary Outcome Measure Information:
    Title
    Inflammatory markers
    Description
    hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
    Time Frame
    8 weeks or more
    Title
    ROTEM - rotation thromboelastometry
    Description
    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.
    Time Frame
    8 weeks or more
    Title
    Metabolic markers
    Description
    Fasting Glucose, HbA1c,Insulin, lipid profile
    Time Frame
    8 weeks or more

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

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    Cholinergic Status and the Metabolic Syndrome

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