Metabolic SyndromeNCT05785117
Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome
A study testing Vagal Stimulation and Circuit training program in people with Metabolic Syndrome, run by Rana Elbanna at 1 site in Egypt.
Trial summary
Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Read more about this study
- Who is it for?
- Ages 45 to 55 years, men only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Vagal Stimulation and Circuit training program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 May 2023
- 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 45 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- having two or more than one of the following:
- Type 2 diabetes Miletus
- Hypertensive.
- Abnormal Cholesterol or Triglyceride level.
- BMI more than 30 kg/m
- Waist circumference more than 94 cm.
Who cannot join
- Vagotomy.
- Diathermy.
- Wallowing difficulties.
- Dyspnea.
- Cardiac arrhythmia.
- Seizure.
- Previous brain injury or surgery.
- Dysautonomia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic faculty of physical therapy at Cairo University
Giza, 12613
About this study
Official title: Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome
Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.
Read the detailed description
Vagus nerve stimulation group Group:
- Each participant signed a consent form after receiving a detailed explanation about the procedure.
- Patients rested on their sides in a sitting position.
- Disinfection of the stimulation locations.
- Ear clips were placed in the ear region (auricular concha) at the stimulation site.
- Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
- Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again.
Circuit training group Group:
- Each participant will signed a consent form after receiving a detailed explanation about the procedure.
- The training regimen included ten different forms of resistance and aerobic exercises.
- Emotional eating was assessed by Emotional Eating Scale.
- Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
5 Cortisol was assessed in lab. 6. After one month all the assessment procedure will be repeated again.
- Conditions
- Metabolic Syndrome
- Being tested
- Vagal Stimulation, Circuit training program
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal StimulationDevice
ear clips were placed in the ear region (auricular concha) at the stimulation site. The following stimulation settings were used: 1) density wave set to 20 Hz with a wave width of less than 1 ms; 2) intensity tuned to the patient's tolerance (4-6 mA)
Circuit training programOther
The training regimen included ten different forms of resistance and aerobic exercise that were done three times a week for four weeks. The resistance training program included push-ups, squats, crunches, lunges, and a superman exercise program that included light jumping, jogging on the spot, foot stomping, steps, and jumping jacks
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve stimulation group | Experimental | Vagus nerve stimulation group Receives: Device: Vagal Stimulation; Other: Circuit training program |
| Circuit weight training group Group | Experimental | Circuit weight training group Group Receives: Other: Circuit training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional eating
Emotional Eating was measured by a 15-item version of the Emotional Eating Scale. The scale required responses from 0 (no desire to eat) to 4 (an overwhelming urge to eat) based on "… the extent which the following feelings presently lead you to feel an urge to eat. A lower score indicated less of an urge to eat when the designated emotional state was present.
Measured: 4 weeks
Patient satisfaction measures
The Short Assessment of Patient Satisfaction (SAPS) is a seven-item scale that can be utilized to measure patient satisfaction with their treatment.
The seven-item Short Assessment of Patient Satisfaction (SAPS), which is scored on a 5-point scale (0-4) SAPS has a continuous score range of 0 to 28. SAPS categorical responses include 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
Measured: 4 weeks
Cortisol level
Participants use a disposable plastic straw to 'drool' saliva into the tube after collecting it in their mouths for a predetermined period of time (one minute) Saliva samples for cortisol measurement kept at room temperature until they are examined in a lab (4 to 6 hours)
Measured: 4 weeks
Secondary outcomes (1)
Body weight
After an eight-hour fast, body weight was taken between 7:00 and 10:00 am using a digital scale that was accurate to ±0.1 kg
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Mar 2023
- Primary completion30 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rana Elbanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rana Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785117
- Sponsor's protocol ID
- P.T.REC/012/003818
- Status last verified
- Aug 2024
- First submitted
- 14 Mar 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elbanna RHM, Elabd SOA, Saleh MSM, Alghitany SIA. Effect of adding noninvasive auricular Vagal nerve stimulation to exercise program on emotional eating and stress responsiveness in patient with metabolic syndrome. Disabil Rehabil. 2025 Dec;47(24):6367-6374. doi: 10.1080/09638288.2025.2506824. Epub 2025 May 17.
PubMed 40382680
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05785117
- Acronym / sponsor ID
- P.T.REC/012/003818
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Rana ElbannaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- 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.
Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.
Detailed description
Vagus nerve stimulation group Group:
- Each participant signed a consent form after receiving a detailed explanation about the procedure.
- Patients rested on their sides in a sitting position.
- Disinfection of the stimulation locations.
- Ear clips were placed in the ear region (auricular concha) at the stimulation site.
- Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
- Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again.
Circuit training group Group:
- Each participant will signed a consent form after receiving a detailed explanation about the procedure.
- The training regimen included ten different forms of resistance and aerobic exercises.
- Emotional eating was assessed by Emotional Eating Scale.
- Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
5 Cortisol was assessed in lab. 6. After one month all the assessment procedure will be repeated again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve stimulation group | Experimental | Device: Vagal Stimulation, Other: Circuit training programVagus nerve stimulation group |
| Circuit weight training group Group | Experimental | Other: Circuit training programCircuit weight training group Group |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 2 diabetes Miletus
- Hypertensive.
- Abnormal Cholesterol or Triglyceride level.
- BMI more than 30 kg/m
- Waist circumference more than 94 cm.
Key exclusion criteria (8 listed)
- Vagotomy.
- Diathermy.
- Wallowing difficulties.
- Dyspnea.
- Cardiac arrhythmia.
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 |
|---|---|---|
| Vagal Stimulationear clips were placed in the ear region (auricular concha) at the stimulation site. The following stimulation settings were used: 1) density wave set to 20 Hz with a wave width of less than 1 ms; 2) intensity tuned to the patient's tolerance (4-6 mA) | Device | Vagus nerve stimulation group |
| Circuit training programThe training regimen included ten different forms of resistance and aerobic exercise that were done three times a week for four weeks. The resistance training program included push-ups, squats, crunches, lunges, and a superman exercise program that included light jumping, jogging on the spot, foot stomping, steps, and jumping jacks | Other | Circuit weight training group Group, Vagus nerve stimulation group |
Primary outcome
Emotional eating
Time frame: 4 weeks
Emotional Eating was measured by a 15-item version of the Emotional Eating Scale. The scale required responses from 0 (no desire to eat) to 4 (an overwhelming urge to eat) based on "… the extent which the following feelings presently lead you to feel an urge to eat. A lower score indicated less of an urge to eat when the designated emotional state was present.
Patient satisfaction measures
Time frame: 4 weeks
The Short Assessment of Patient Satisfaction (SAPS) is a seven-item scale that can be utilized to measure patient satisfaction with their treatment. The seven-item Short Assessment of Patient Satisfaction (SAPS), which is scored on a 5-point scale (0-4) SAPS has a continuous score range of 0 to 28. SAPS categorical responses include 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
Cortisol level
Time frame: 4 weeks
Participants use a disposable plastic straw to 'drool' saliva into the tube after collecting it in their mouths for a predetermined period of time (one minute) Saliva samples for cortisol measurement kept at room temperature until they are examined in a lab (4 to 6 hours)
1 secondary outcome
Body weight
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 40382680Elbanna RHM, Elabd SOA, Saleh MSM, Alghitany SIA. Effect of adding noninvasive auricular Vagal nerve stimulation to exercise program on emotional eating and stress responsiveness in patient with metabolic syndrome. Disabil Rehabil. 2025 Dec;47(24):6367-6374. doi: 10.1080/09638288.2025.2506824. Epub 2025 May 17.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Stimulation and Circuit training program in people with Metabolic Syndrome, run by Rana Elbanna at 1 site in Egypt.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotional eating (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05785117, which also lists 1 linked publication.
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 14 Aug 2024.