Effect of Tvns in Obesity

NCT ID: NCT07334951

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-11

Study Completion Date

2026-08-21

Brief Summary

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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.

Detailed Description

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

Conditions

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Obesity and Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

They will receive TVNS for 45 min , 3times per week inaddition to dietary advices for months.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Sham tVNS for 45 min 3 times per week in addition to dietary advices for 3 months .

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Trans vagus nerve stimulation electrical device.

Intervention Type DEVICE

Tvns located at auricular concha area For 45min three times per week for 3 months.

Control group

Sham TVNS 45 min for 3 months with dietary advices .

Group Type SHAM_COMPARATOR

Trans vagus nerve stimulation electrical device.

Intervention Type DEVICE

Tvns located at auricular concha area For 45min three times per week for 3 months.

Interventions

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Trans vagus nerve stimulation electrical device.

Tvns located at auricular concha area For 45min three times per week for 3 months.

Intervention Type DEVICE

Other Intervention Names

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TVNS electrical device .

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Enas Wagdy Elsaid Ahmed

Effect of auricular vagus nerve stimulation on glucose tolerance, and mood states in obesity

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta general hospital

Tanta, Algarbia, Egypt

Site Status

Countries

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Egypt

References

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Barazzoni R metal 2023 ,aerobic training

Reference Type RESULT

Study Documents

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Document Type: Study Protocol

No comments

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Other Identifiers

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TVNS in obesity effects

Identifier Type: -

Identifier Source: org_study_id

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