Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-18
Brief Title:
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With MASLD
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
The Efficacy of Pedometer-motivated Physical Activity for the Management of Patients With Metabolic-associated Steatotic Liver Disease a Randomized-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The study conducted a health survey among Thai adults in 2022 and found a significant increase in obesity and nonalcoholic fatty liver disease NAFLD leading to metabolic-associated steatotic liver disease MASLD The prevalence of NAFLD was 197 with higher rates in individuals with metabolic syndrome and diabetes MASLD is associated with insulin resistance and genetic polymorphisms particularly the patatin like phospholipase domain containing 3-rs738409 variant Additionally physical activity was inversely related to liver disease risk with higher step counts associated with reduced incidence of NAFLD and liver-related mortality The study aims to investigate the impact of dietary advice and pedometer use on physical activity levels and health outcomes in MASLD patients over 24 weeks
Detailed Description:
The results of the health survey of the Thai population through physical examinations in the year 2022 found that among Thai people aged 18 and older the prevalence of obesity BMI 25 kgm2 was 449 403 in males and 492 in females which has increased significantly over the past decades This condition is a significant factor contributing to the rising incidence of nonalcoholic fatty liver disease NAFLD among the Thai population NAFLD refers to fatty liver disease in individuals who consume alcohol in amounts less than 140 grams per week for females or less than 210 grams per week for males Those with clinical features of metabolic dysfunction have been newly defined as having metabolic-associated steatotic liver disease MASLD
In this survey of 18588 individuals the prevalence of NAFLD was 197 with rates of 209 in males and 186 in females It was notably higher at 435 in individuals with abdominal obesity metabolic syndrome and 356 in individuals with diabetes Factors such as age sex physical activity smoking and metabolic characteristics such as overweight or obesity abdominal obesity high triglyceride levels diabetes hypertension and low HDL cholesterol levels are significantly associated with NAFLD
MASLD a type of fatty liver disease is directly associated with insulin resistance a key risk factor for cardiovascular diseases Current treatment guidelines for MASLD have clear evidence that weight loss through dietary control and appropriate physical activity or exercise can reduce fat accumulation in the liver inflammation and fibrosis Importantly it also improves various metabolic parameters such as blood sugar and lipid levels as well as the effectiveness of insulin
The etiology of MASLD is related to behavioral and environmental factors such as high-calorie diets combined with low physical activity and sedentary lifestyles These factors promote insulin resistance stimulating lipolysis and the movement of free fatty acids to various organs including the liver This leads to fat accumulation in the liver insulin-resistant hepatic tissue abnormal β-oxidation processes oxidative stress hepatic inflammation increased stellate cell activation and subsequent fibrosis eventually increasing the risk of liver cirrhosis and hepatocellular carcinoma
Genetic polymorphisms play a significant role in MASLD pathogenesis with single nucleotide polymorphisms SNPs in the patatin like phospholipase domain containing-3 gene particularly the rs738409 variant being strongly associated with fat accumulation and fibrosis in the liver
Furthermore a systematic review and analysis of data from 12 studies involving 111309 individuals found that the number of steps per day particularly 8800 steps per day was associated with a significant reduction in the risk of overall mortality and cardiovascular diseases CVD Additionally increasing physical activity was associated with a reduced risk of chronic liver disease overall and NAFLD specifically Increasing physical activity by 2500 steps per day was associated with a 38 reduction in chronic liver disease and a 47 reduction in NAFLD regardless of obesity status
This research aims to conduct a randomized study to provide advice to MASLD patients to modify their diet and wear pedometers to encourage changes in physical activity with a goal of achieving at least 8800 steps per day compared to MASLD patients who only receive dietary advice and wear pedometers to record daily steps over a 24-week period
In this survey of 18588 individuals the prevalence of NAFLD was 197 with rates of 209 in males and 186 in females It was notably higher at 435 in individuals with abdominal obesity metabolic syndrome and 356 in individuals with diabetes Factors such as age sex physical activity smoking and metabolic characteristics such as overweight or obesity abdominal obesity high triglyceride levels diabetes hypertension and low HDL cholesterol levels are significantly associated with NAFLD
MASLD a type of fatty liver disease is directly associated with insulin resistance a key risk factor for cardiovascular diseases Current treatment guidelines for MASLD have clear evidence that weight loss through dietary control and appropriate physical activity or exercise can reduce fat accumulation in the liver inflammation and fibrosis Importantly it also improves various metabolic parameters such as blood sugar and lipid levels as well as the effectiveness of insulin
The etiology of MASLD is related to behavioral and environmental factors such as high-calorie diets combined with low physical activity and sedentary lifestyles These factors promote insulin resistance stimulating lipolysis and the movement of free fatty acids to various organs including the liver This leads to fat accumulation in the liver insulin-resistant hepatic tissue abnormal β-oxidation processes oxidative stress hepatic inflammation increased stellate cell activation and subsequent fibrosis eventually increasing the risk of liver cirrhosis and hepatocellular carcinoma
Genetic polymorphisms play a significant role in MASLD pathogenesis with single nucleotide polymorphisms SNPs in the patatin like phospholipase domain containing-3 gene particularly the rs738409 variant being strongly associated with fat accumulation and fibrosis in the liver
Furthermore a systematic review and analysis of data from 12 studies involving 111309 individuals found that the number of steps per day particularly 8800 steps per day was associated with a significant reduction in the risk of overall mortality and cardiovascular diseases CVD Additionally increasing physical activity was associated with a reduced risk of chronic liver disease overall and NAFLD specifically Increasing physical activity by 2500 steps per day was associated with a 38 reduction in chronic liver disease and a 47 reduction in NAFLD regardless of obesity status
This research aims to conduct a randomized study to provide advice to MASLD patients to modify their diet and wear pedometers to encourage changes in physical activity with a goal of achieving at least 8800 steps per day compared to MASLD patients who only receive dietary advice and wear pedometers to record daily steps over a 24-week period
Study Oversight
Has Oversight DMC:
None
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?:
None