CClinicalTrials.gg
CompletedNCT05785117Updated Aug 14, 2024

Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

An interventional study of Vagal Stimulation and Circuit training program in Metabolic Syndrome, sponsored by Rana Elbanna. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Rana Elbanna · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
Male
01

Study 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. 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:

  1. Each participant signed a consent form after receiving a detailed explanation about the procedure.
  2. Patients rested on their sides in a sitting position.
  3. Disinfection of the stimulation locations.
  4. Ear clips were placed in the ear region (auricular concha) at the stimulation site.
  5. Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS).
  6. Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again.

Circuit training group Group:

  1. Each participant will signed a consent form after receiving a detailed explanation about the procedure.
  2. The training regimen included ten different forms of resistance and aerobic exercises.
  3. Emotional eating was assessed by Emotional Eating Scale.
  4. 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.

02

Conditions studied

  • Metabolic Syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Rana Elbanna is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • Vagotomy.
  • Diathermy.
  • Wallowing difficulties.
  • Dyspnea.
  • Cardiac arrhythmia.
  • Seizure.
  • Previous brain injury or surgery.
  • Dysautonomia.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Vagus nerve stimulation group

    Vagus nerve stimulation group

    Device: Vagal Stimulation · Other: Circuit training program

  • Experimental
    Circuit weight training group Group

    Circuit weight training group Group

    Other: Circuit training program

Interventions

  • DeviceVagal Stimulation

    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)

  • OtherCircuit training program

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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)

    Time frame: 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

    Time frame: 4 weeks

07

Study locations

1 site
  • Outpatient clinic faculty of physical therapy at Cairo University
    Giza, 12613, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05785117
Lead sponsor
Rana Elbanna
Responsible party
Rana Elbanna (lecturer at faculty of physical therapy at Cairo University, Cairo University) — Sponsor-investigator
First posted
Mar 27, 2023
Start date
Mar 1, 2023
Primary completion
Apr 30, 2023
Completion
May 30, 2023
Last update
Aug 14, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion