Effect of Tvns in Obesity

NCT07334951 | Active Not Recruiting DMC

• 1 other identifier: TVNS in obesity effects
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity and Diabetes Mellitus, Type 2

Keywords

Protection from diabetes in obesity

Outcome Measures

Primary Outcomes (1)

• Glucose tolerance.

  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 Outcomes (2)

• Insulin resistance.

  Baseline and after 12th weeks of intervention.

• Insulin sensitvity.

  Baseline and after 12th weeks of intervention.

Other Outcomes (6)

• Body mass index

  Baseline and after 12 weeks of intervention.

• Waist circumference.

  Baseline and 12 weeks after the intervention.

• Body fat percentage.

  Baseline and after 12 weeks of intervention.

Study Arms (2)

Effect of tvns in glucose tolerance ,insulin resistance,stress hormones ,and mood states in obesity

ACTIVE COMPARATOR

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.

Control group

SHAM COMPARATOR

Sham TVNS 45 min for 3 months with dietary advices .

Device: Trans vagus nerve stimulation electrical device.

Interventions

Trans vagus nerve stimulation electrical device. DEVICE

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

Also known as: TVNS electrical device .

Control group; Effect of tvns in glucose tolerance ,insulin resistance,stress hormones ,and mood states in obesity

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Tanta general hospital

Tanta, Algarbia, 31511, Egypt

Location

Related Publications (1)

• Barazzoni R metal 2023 ,aerobic training

  RESULT

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham tVNS for 45 min 3 times per week in addition to dietary advices for 3 months .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of auricular vagus nerve stimulation on glucose tolerance, and mood states in obesity

Model Details: They will receive TVNS for 45 min , 3times per week inaddition to dietary advices for months.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 12, 2026
• Study Start: January 11, 2026
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-09

Locations

EG (1)