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
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
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
NCT ID
NCT01332708
First Posted
April 7, 2011
Last Updated
April 8, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
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
Learn more about this trial
Cholinergic Status and the Metabolic Syndrome
We'll reach out to this number within 24 hrs