Effect of Tvns in Obesity (TVNS EFFECTS)

Cairo University (CU)

Status: Active, not recruiting

Conditions: Obesity and Diabetes Mellitus, Type 2

Treatments: Device: Trans vagus nerve stimulation electrical device.

Study type: Interventional

Funder types: Other

Identifiers

NCT07334951

TVNS in obesity effects

Details and patient eligibility

About

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.

Full description

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

Enrollment: 70 estimated patients

Sex: All

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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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Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

Device: Trans vagus nerve stimulation electrical device.

Control group

Sham Comparator group

Description:

Sham TVNS 45 min for 3 months with dietary advices .

Treatment:

Device: Trans vagus nerve stimulation electrical device.