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Completed

NCT Number: NCT05785117

Vagal Nerve Stimulation as Therapeutic Approach on 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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic faculty of physical therapy at Cairo University

Giza, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vagal stimulation

Device

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)

Circuit training program

Other

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 outcomes

  1. Emotional eating

    Time frame: 4 weeks

    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.

  2. Patient satisfaction measures

    Time frame: 4 weeks

    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.

  3. Cortisol level

    Time frame: 4 weeks

    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 outcomes

  1. Body weight

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

Rana Elbanna

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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