Clinical trial NCT05785117: Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome
Official title: Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 70
Sex: MALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Emotional eating
timeFrame: 4 weeks
measure: Patient satisfaction measures
timeFrame: 4 weeks
measure: Cortisol level
timeFrame: 4 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient clinic faculty of physical therapy at Cairo University
Study officials:
References: