Cholinergic Status and the Metabolic Syndrome (Choliner stat)

April 8, 2011 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: high complex carbohydrates diet given in a diet group
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

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 11, 2011

Last Update Submitted That Met QC Criteria

April 8, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

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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