Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Device: Vagal Stimulation; Other: Circuit training program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana H El-Banna, PHD; Phone Number: 002 01062070686; Email: rana.hesham@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Recruiting
    • Outpatient clinic faculty of physical therapy at Cairo University
    • Contact: Mohamed O Hesham, PHD; Phone Number: 00201067227404; Email: shiref.elabd@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vagus nerve stimulation group	Device: Vagal 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)
Experimental: Circuit weight training group Group	Other: Circuit 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rana Elbanna

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: Dr Rana Hesham

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No