Effect of Tvns in Obesity (TVNS EFFECTS)

January 12, 2026 updated by: Enas Wagdy Elsaid Ahmed, Cairo University

Effect of AURICULAR Vagus Nerve Stimulation on Glucose Tolerance, and Mood States in Obesity

Avoid unhealthy foods, walk every day for at least 15 min , sleep well, he should take sessions at its time, family should Avoid disturbances, keep quiet as much as possible, make Analysis recoired before and after interaction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Pre and post Anthrompometric measurement,waist circumference, body composition, lab tests, mood assessment, tVNS application, data management will be carried out using SPSSv26.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Algarbia
      • Tanta, Algarbia, Egypt, 31511
        • Tanta General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:40_50years Both sexes , BMI more than or equal 30 kg/m2 FBG less than 7 mmol/l 2hpp between 7.8 and 11.1mmol/l at the time of enrollment . HOMA-IR >2.9 All are sedentary level activities.

Exclusion Criteria:Diagnostic type 1and 2 DM Cardiovascular disease, stroke, uncontrolled hypertension Use psychoactive drugs, antiepliptic drugs, antidepressants. Present of metal implants, pace maker or cochlear implants. History of epilepsy or seizours . Pregnancy or breast feeding. Dermatologist condition near stimulating site. Major psychiatric disorders.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Effect of tvns in glucose tolerance ,insulin resistance,stress hormones ,and mood states in obesity

All patients received transcutaneous electrical nerve stimulation. Allsubsequent ttt will be 3 times per week for 12weeks .

Patients will also instructed to complete diary booklet each day to describe side effects corresponding with or temporally related to ttt.

The investigators checked all booklets at the 6 and 12 week assessments. The points for tvns are located in the auricular concha area where there is rich vagus nerve branch distribution.

Stimulation parameters will be 1MA of electrical current frequency of 20 HZ with pulse duration less than or equal 1ms ,administration once daily lasted 45 min the intensity adjusted based on the individual tolerance of patients.

Control group Sham tavns ttt location at the superior scapha , where no vagus nerve distribution, after final session, all baseline measurements will be repeated using the same procedures .

All data will be anonymized and stored securely .data will be verified by double _checked , and analysis by SPSS v26.
Device: Trans vagus nerve stimulation electrical device.
Tvns located at auricular concha area For 45min three times per week for 3 months.
Other Names:
  • TVNS electrical device .
Sham Comparator: Control group
Sham TVNS 45 min for 3 months with dietary advices .
Device: Trans vagus nerve stimulation electrical device.
Tvns located at auricular concha area For 45min three times per week for 3 months.
Other Names:
  • TVNS electrical device .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance.
Time Frame: Baseline and after 12th weeks of intervention.
Change in glucose tolerance assessed using 2_hours oral glucose tolerance test (OGTT), expressed as glucose plasma area under curve (AUC), following a75 g oral glucose load.
Baseline and after 12th weeks of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance.
Time Frame: Baseline and after 12th weeks of intervention.
Change in insulin resistance assessed using homeostasis model assessment of insulin resistance (HOMA-IR), calculated from fasting plasma glucose tolerance test and fasting insulin levels.
Baseline and after 12th weeks of intervention.
Insulin sensitvity.
Time Frame: Baseline and after 12th weeks of intervention.
Change in insulin sensitvity assessed using the Matsuda and Defronzo insulin sensitvity index (ISI), derived from oral glucose tolerance values.
Baseline and after 12th weeks of intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: Baseline and after 12 weeks of intervention.
Change in body mass index calculated as weight in kilograms divided by height in meter square (kg/m2).
Baseline and after 12 weeks of intervention.
Waist circumference.
Time Frame: Baseline and 12 weeks after the intervention.
Change in waist circumference measured in centimeters at the midpoint between the lowest rib and the ilkac crest
Baseline and 12 weeks after the intervention.
Body fat percentage.
Time Frame: Baseline and after 12 weeks of intervention.
Change in fat percentage assessed using the sum of four skin fold thickness measurements (tricepes, suprailiac, abdominal ,and thigh) and calculated using sex specific equations.
Baseline and after 12 weeks of intervention.
Stress hormones ( serum cortisol levels ).
Time Frame: Baseline and after 12 weeks of intervention.
Change in serum cortisol level measured by chemiluminesence immunoassey
Baseline and after 12 weeks of intervention.
Stress hormones ( ACTH ).
Time Frame: Baseline and after 12 weeks of intervention.
Change in serum ACTH level measured by chemiluminesence immunoassey
Baseline and after 12 weeks of intervention.
Mood states.
Time Frame: Baseline and after 12th weeks of intervention
Change in mood states assessed using by the profile of mood states _short form (POMS-SF) , using the total mood disturbance score and subscale scores .
Baseline and after 12th weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Barazzoni R metal 2023 ,aerobic training

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2026

Primary Completion (Estimated)

August 21, 2026

Study Completion (Estimated)

August 21, 2026

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVNS in obesity effects

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information identifier: enaswagdydaib@gmail.com
    Information comments: No comments

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity and Diabetes Mellitus, Type 2

Clinical Trials on Trans vagus nerve stimulation electrical device.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe