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Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vagal Stimulation
Circuit training program
Sponsored by
Rana Elbanna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

45 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Outpatient clinic faculty of physical therapy at Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vagus nerve stimulation group

Circuit weight training group Group

Arm Description

Vagus nerve stimulation group

Circuit weight training group Group

Outcomes

Primary Outcome Measures

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.
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.
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)

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2023
Last Updated
March 14, 2023
Sponsor
Rana Elbanna
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1. Study Identification

Unique Protocol Identification Number
NCT05785117
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rana Elbanna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagus nerve stimulation group
Arm Type
Experimental
Arm Description
Vagus nerve stimulation group
Arm Title
Circuit weight training group Group
Arm Type
Experimental
Arm Description
Circuit weight training group Group
Intervention Type
Device
Intervention Name(s)
Vagal Stimulation
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Circuit training program
Intervention Description
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
Primary Outcome Measure Information:
Title
Emotional eating
Description
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
Title
Patient satisfaction measures
Description
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
Title
Cortisol level
Description
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 Outcome Measure Information:
Title
Body weight
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana H El-Banna, PHD
Phone
01062070686
Ext
002
Email
rana.hesham@pt.cu.edu.eg
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy at Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed O Hesham, PHD
Phone
00201067227404
Email
shiref.elabd@yahoo.com

12. IPD Sharing Statement

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Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

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