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Active, Not Recruiting

NCT Number: NCT07334951

Effect of Tvns 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity and Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta general hospital

Tanta, Algarbia, 31511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

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Treatment and study plan

Trans vagus nerve stimulation electrical device.

Device

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

Other names: TVNS electrical device .

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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).

  2. 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

  3. 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.

  4. Stress hormones ( serum cortisol levels ).

    Time frame: Baseline and after 12 weeks of intervention.

    Change in serum cortisol level measured by chemiluminesence immunoassey

  5. Stress hormones ( ACTH ).

    Time frame: Baseline and after 12 weeks of intervention.

    Change in serum ACTH level measured by chemiluminesence immunoassey

  6. 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 .

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: TVNS EFFECTS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 13, 2026

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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