- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01332708
Cholinergic Status and the Metabolic Syndrome (Choliner stat)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
diet groups that meet every week for eight weeks or more.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total soluble circulation capacity for acetylcholine hydrolysis
Time Frame: 8 weeks or more
|
8 weeks or more
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory markers
Time Frame: 8 weeks or more
|
hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
|
8 weeks or more
|
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.
|
8 weeks or more
|
Metabolic markers
Time Frame: 8 weeks or more
|
Fasting Glucose, HbA1c,Insulin, lipid profile
|
8 weeks or more
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-11-SB-10-538-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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