Cholinergic Status and the Metabolic Syndrome

Overweight Clinical Trial

— Choliner stat  

Official title:

Cholinergic Status and the Metabolic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01332708
• Other study ID #: TASMC-11-SB-10-538-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2011
• Last updated: April 8, 2011
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Obese
• Overweight

Intervention

Behavioral:
• high complex carbohydrates diet given in a diet group
diet groups that meet every week for eight weeks or more.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total soluble circulation capacity for acetylcholine hydrolysis		8 weeks or more	No
Secondary	Inflammatory markers	hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-a	8 weeks or more	No
Secondary	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.	8 weeks or more	No
Secondary	Metabolic markers	Fasting Glucose, HbA1c,Insulin, lipid profile	8 weeks or more	No