Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT07200934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to identify the effect of adding TENS to the Mediterranean diet on appetite and liver enzymes in Nonalcoholic fatty liver patients.
Detailed Description:
Nonalcoholic fatty liver disease (NAFLD), also termed metabolic dysfunction-associated fatty liver disease, is one of the most common chronic liver diseases worldwide. The development of NAFLD is fueled by a sedentary lifestyle, low frequency of physical activity, unhealthy diet and excessive calorie intake. NAFLD is characterized by fat accumulation in the liver accounting for \>5% of hepatic tissue weight (fatty liver), as well as liver inflammation, which is not caused by alcohol abuse.
NAFLD prevalence is on the rise, mainly due to the presence of the obesity epidemic. Nowadays, NAFLD has been suggested to affect approximately 25% of the population worldwide. they have found a greater increase among men than women regarding the prevalence of NAFLD. Moreover, its mortality is projected to approach an increase of 65% to 100% by 2030 in Asian-Pacific regions.
Globally, NAFLD prevalence averages 24.1%, ranging from 13.5% in Africa to 31.8% in the Middle East. Despite limited data on the extent of NAFLD in Egypt, the available data indicate a prevalence of nearly 32% among Egyptians, compared to a global prevalence of 25% Egypt ranks among the top ten countries with the highest obesity rates in the world.
Lifestyle modifications are the cornerstone of NAFLD management. A Mediterranean diet (MD), rich in whole grains, vegetables, fruits, nuts, and olive oil, is proven to improve liver health by reducing inflammation and fat accumulation.
Transcutaneous electrical stimulation (TENS) of T6 dermatome on the abdomen generates impulses which are carried to the spinal cord via afferent pathways, in turn, efferent impulses pass through the vagus nerve, and effects are induced similar to the gastric stimulator .This somato-autonomic reflex helps in decreasing appetite.
Therefore, the primary aim of this study it will impact future researcher about the beneficial effect of T6 dermatomal stimulation by the transcutaneous method in managing obesity, improving liver function and finally promoting body health related measure in non-alcoholic fatty liver patients.
NAFLD prevalence is on the rise, mainly due to the presence of the obesity epidemic. Nowadays, NAFLD has been suggested to affect approximately 25% of the population worldwide. they have found a greater increase among men than women regarding the prevalence of NAFLD. Moreover, its mortality is projected to approach an increase of 65% to 100% by 2030 in Asian-Pacific regions.
Globally, NAFLD prevalence averages 24.1%, ranging from 13.5% in Africa to 31.8% in the Middle East. Despite limited data on the extent of NAFLD in Egypt, the available data indicate a prevalence of nearly 32% among Egyptians, compared to a global prevalence of 25% Egypt ranks among the top ten countries with the highest obesity rates in the world.
Lifestyle modifications are the cornerstone of NAFLD management. A Mediterranean diet (MD), rich in whole grains, vegetables, fruits, nuts, and olive oil, is proven to improve liver health by reducing inflammation and fat accumulation.
Transcutaneous electrical stimulation (TENS) of T6 dermatome on the abdomen generates impulses which are carried to the spinal cord via afferent pathways, in turn, efferent impulses pass through the vagus nerve, and effects are induced similar to the gastric stimulator .This somato-autonomic reflex helps in decreasing appetite.
Therefore, the primary aim of this study it will impact future researcher about the beneficial effect of T6 dermatomal stimulation by the transcutaneous method in managing obesity, improving liver function and finally promoting body health related measure in non-alcoholic fatty liver patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: