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Cholinergic Status and the Metabolic Syndrome

Cholinergic Status and the Metabolic Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01332708
Acronym
Choliner stat
Enrollment
50
Registered
2011-04-11
Start date
2011-04-30
Completion date
2011-09-30
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight

Keywords

high complex carbohydrates, hypocaloric diet, cholinergic status, overweight, obese

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.

Interventions

BEHAVIORALhigh complex carbohydrates diet given in a diet group

diet groups that meet every week for eight weeks or more.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
total soluble circulation capacity for acetylcholine hydrolysis8 weeks or more

Secondary

MeasureTime frameDescription
Inflammatory markers8 weeks or morehs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
ROTEM - rotation thromboelastometry8 weeks or moreROTEM 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 markers8 weeks or moreFasting Glucose, HbA1c,Insulin, lipid profile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026