Obesity and Diabetes Mellitus, Type 2TVNS EFFECTSNCT07334951
Effect of Tvns in Obesity
A study testing Trans vagus nerve stimulation electrical device. in people with Obesity and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Obesity and Diabetes Mellitus, Type 2
- What is being tested?
- Trans vagus nerve stimulation electrical device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2026to 21 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity and Diabetes Mellitus, Type 2
- Being tested
- Trans vagus nerve stimulation electrical device.
- Keywords
- Protection from diabetes in obesity
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans vagus nerve stimulation electrical device.Device
Also called TVNS electrical device .
Tvns located at auricular concha area For 45min three times per week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Trans vagus nerve stimulation electrical device. |
| Control group | Sham comparator | Sham TVNS 45 min for 3 months with dietary advices . Receives: Device: Trans vagus nerve stimulation electrical device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 12th weeks of intervention.
Secondary outcomes (2)
Insulin resistance.
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.
Measured: Baseline and after 12th weeks of intervention.
Insulin sensitvity.
Change in insulin sensitvity assessed using the Matsuda and Defronzo insulin sensitvity index (ISI), derived from oral glucose tolerance values.
Measured: Baseline and after 12th weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start11 Jan 2026
- Primary completion21 Aug 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- They will receive TVNS for 45 min , 3times per week inaddition to dietary advices for months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Wagdy Elsaid Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334951
- Sponsor's protocol ID
- TVNS in obesity effects
- Acronym
- TVNS EFFECTS
- Status last verified
- Sep 2025
- First submitted
- 30 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barazzoni R metal 2023 ,aerobic training
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AURICULAR Vagus Nerve Stimulation on Glucose Tolerance, and Mood States in Obesity
- ClinicalTrials.gov ID
- NCT07334951
- Acronym / sponsor ID
- TVNS EFFECTS / TVNS in obesity effects
- Conditions
- Obesity and Diabetes Mellitus, Type 2
- Keywords
- Protection from diabetes in obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jan 2026 (actual)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Pre and post Anthrompometric measurement,waist circumference, body composition, lab tests, mood assessment, tVNS application, data management will be carried out using SPSSv26.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- They will receive TVNS for 45 min , 3times per week inaddition to dietary advices for months.
| Arm | Type | Receives |
|---|---|---|
| Effect of tvns in glucose tolerance ,insulin resistance,stress hormones ,and mood states in obesity | Active comparator | Device: Trans vagus nerve stimulation electrical device.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. |
| Control group | Sham comparator | Device: Trans vagus nerve stimulation electrical device.Sham TVNS 45 min for 3 months with dietary advices . |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans vagus nerve stimulation electrical device.Also: TVNS electrical device .Tvns located at auricular concha area For 45min three times per week for 3 months. | Device | Control group, Effect of tvns in glucose tolerance ,insulin resistance,stress hormones ,and mood states in obesity |
Primary outcome
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.
2 secondary outcomes
Insulin resistance.
Time frame: Baseline and after 12th weeks of intervention.
Insulin sensitvity.
Time frame: Baseline and after 12th weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publicationBarazzoni R metal 2023 ,aerobic training
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans vagus nerve stimulation electrical device. in people with Obesity and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance. (time frame: Baseline and after 12th weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.