Cholinergic Status and the Metabolic Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01332708
• Date of registration: 07/04/2011
• Primary sponsor: Tel-Aviv Sourasky Medical Center
• Public title: Cholinergic Status and the Metabolic Syndrome Choliner stat
• Scientific title: Cholinergic Status and the Metabolic Syndrome
• Date of first enrolment: April 2011
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01332708
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Key inclusion & exclusion 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



Age minimum: 35 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obese

Overweight

Intervention(s)

Behavioral: high complex carbohydrates diet given in a diet group

Primary Outcome(s)

total soluble circulation capacity for acetylcholine hydrolysis [Time Frame: 8 weeks or more]

Secondary Outcome(s)

Inflammatory markers [Time Frame: 8 weeks or more]

Metabolic markers [Time Frame: 8 weeks or more]

ROTEM - rotation thromboelastometry [Time Frame: 8 weeks or more]

Secondary ID(s)

TASMC-11-SB-10-538-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors