Metabolic Dysfunction-Associated Steatotic Liver Disease in adolescents Digestive System
Conditions
Interventions
The patients will be assigned into one of the two group studies, using a table with random numbers. Group 1 will receive recommendations in changes of lifestyle that include orientation over diet and
the patient will receive this information in writing.
In week 0 and week 12, the Controlled Attenuation Parameter will be evaluated in the patients of both groups. In both weeks 0 and 12, the research
Sponsors
Mexican Social Security Institute
Eligibility
Sex/Gender
All
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Adolescent patients, from ages 10 to 17 years, of any sex, with the diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease 2. Adolescentes with an established diagnosis of Steatotic Liver disease by ultrasonography, presence of overweight or obesity according to the Z-score Z =1 BMI, with reference parameters of the WHO 3. Parents of the patient must have a phone number 4. Patients that receive follow-up at the outpatient consultation on the Nutrition, pediatric endocrinology and pediatric gastroenterology areas, at the Instituto Mexicano del Seguro Social, Unidad Médica de Alta Especialidad No. 48, Hospital de Gineco Pediatría, Centro Médico Nacional del Bajío
Exclusion criteria
Exclusion criteria: 1. Patients with the diagnosis of a previous Drug Induced Liver Injury, Viral Hepatitis B or C infection or HIV infection 2. Patients with alcohol ingestion greater than 140 g per week in women or greater than 210 g per week on men 3. History of congenital hepatic disease, autoimmune diseases, primary hypothyroidism, psychiatric disorders or chronic kidney disease 4. Allergy to flaxseed or wheat 5. Patients treated with either one or more of the following medications: steroids, hypoglycemic agents, hypolipidemic agents, vitamin supplements, docosahexaenoic acid, eicosapentaenoic acid, antibiotics or herbal therapy 6. Patients with physical or sensorial disabilities 7. Pregnant or breastfeeding patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter will be measured with Fibroscan, at weeks 0 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In weeks 0, 6 and 12, the nutritional profile will be evaluated with the BMI, waist circumference, blood pressure and laboratory testing regarding the liver function (ALT, AST, GGT, LDH), lipid profile (LDL, HDL, cholesterol, tryglycerides) and fasting blood glucose 3. The Daily Intake of Energy will be evaluated with the Frequency of Food Consumption Survey at weeks 0, 6 and 12 4. On weeks 0, 6 and 12, physical activity will be evaluated with a podometer that will assess the average of the amount of steps taken in a 5 day period 5. Presence of adverse effects will be evaluated with the presence of any gastrointestinal symptoms like diarrhea or abdominal pain | — |
Countries
Mexico
Contacts
Public ContactGloria Patricia Sosa-Bustamante
Outcome results
None listed