Obesity and Diabetes Mellitus, Type 2
Conditions
Keywords
Protection from diabetes in obesity
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.
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.
Interventions
DEVICETrans vagus nerve stimulation electrical device.
Tvns located at auricular concha area For 45min three times per week for 3 months.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Sham tVNS for 45 min 3 times per week in addition to dietary advices for 3 months .
Intervention model description
They will receive TVNS for 45 min , 3times per week inaddition to dietary advices for months.
Eligibility
Sex/Gender
ALL
Age
40 Years to 50 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose tolerance. | 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
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance. | 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. |
| Insulin sensitvity. | 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
| Measure | Time frame | Description |
|---|---|---|
| Stress hormones ( serum cortisol levels ). | Baseline and after 12 weeks of intervention. | Change in serum cortisol level measured by chemiluminesence immunoassey |
| Body mass index | 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). |
| Mood states. | 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 . |
| Stress hormones ( ACTH ). | Baseline and after 12 weeks of intervention. | Change in serum ACTH level measured by chemiluminesence immunoassey |
| Waist circumference. | 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 |
| Body fat percentage. | 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. |
Countries
Egypt
Outcome results
None listed