OverweightCholiner statNCT01332708
Cholinergic Status and the Metabolic Syndrome
A study testing high complex carbohydrates diet given in a diet group in people with Overweight and Obese, run by Tel-Aviv Sourasky Medical Center.
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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- high complex carbohydrates diet given in a diet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 25kg/m2
- Stable weight (±1kg)in the previous six months
- Non smokers
Who cannot join
- Type II diabetes
- Hypertension pharmacologically treated
- Cardiovascular disease
- Renal disease
- Cirrhosis and end-stage liver failure
- Thyroid disease
Show all 12Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Overweight, Obese
- Being tested
- high complex carbohydrates diet given in a diet group
- Keywords
- high complex carbohydrates, hypocaloric diet, cholinergic status, overweight, obese
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high complex carbohydrates diet given in a diet groupBehavioural
diet groups that meet every week for eight weeks or more.
| Study group | Role | What they receive |
|---|---|---|
| Obese and overweight subjects | Experimental | The participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups. Receives: Behavioral: high complex carbohydrates diet given in a diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
total soluble circulation capacity for acetylcholine hydrolysis
Measured: 8 weeks or more
Secondary outcomes (3)
Inflammatory markers
hs-CRP, ESR, Fibrinogen, IL-1b, IL-6, TNF-α
Measured: 8 weeks or more
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.
Measured: 8 weeks or more
Metabolic markers
Fasting Glucose, HbA1c,Insulin, lipid profile
Measured: 8 weeks or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332708
- Sponsor's protocol ID
- TASMC-11-SB-10-538-CTIL
- Acronym
- Choliner stat
- Status last verified
- Apr 2011
- First submitted
- 7 Apr 2011
- Last updated
- 11 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholinergic Status and the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01332708
- Acronym / sponsor ID
- Choliner stat / TASMC-11-SB-10-538-CTIL
- Conditions
- Overweight, Obese
- Keywords
- high complex carbohydrates, hypocaloric diet, cholinergic status, overweight, obese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese and overweight subjects | Experimental | Behavioral: high complex carbohydrates diet given in a diet groupThe participants are overweight and obese people with and without metabolic syndrome that will participate in diet groups. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 25kg/m2
- Stable weight (±1kg)in the previous six months
- Non smokers
Key exclusion criteria (12 listed)
- Type II diabetes
- Hypertension pharmacologically treated
- Cardiovascular disease
- Renal disease
- Cirrhosis and end-stage liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high complex carbohydrates diet given in a diet groupdiet groups that meet every week for eight weeks or more. | Behavioural | Obese and overweight subjects |
Primary outcome
total soluble circulation capacity for acetylcholine hydrolysis
Time frame: 8 weeks or more
3 secondary outcomes
Inflammatory markers
Time frame: 8 weeks or more
ROTEM - rotation thromboelastometry
Time frame: 8 weeks or more
Metabolic markers
Time frame: 8 weeks or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing high complex carbohydrates diet given in a diet group in people with Overweight and Obese, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total soluble circulation capacity for acetylcholine hydrolysis (time frame: 8 weeks or more). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2011.