Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Device: Vagal Stimulation
* Other: Circuit training program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vagus nerve stimulation group<br>Vagus nerve stimulation group | Device: Vagal Stimulation<br>* 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)<br>|
| Experimental: Circuit weight training group Group<br>Circuit weight training group Group | Other: Circuit training program<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks |