Low Carbohydrate Diet: The Effects on Non Alcoholic Fatty Liver Disease in Obese Teens
Study ID: STU 082013-020
Design: our study is a 6-month prospective randomized controlled trial with outcomes assessment monthly for the first 6 months and a follow up visit at 10-12 months after randomization. Subjects: all patients referred (male and female) within the age range of 11 x 17 years who are obese (BMi [Greater Than][?] 95th percentile) and meet criteria for metabolic syndrome (MetS) and non alcoholic fatty liver disease (naFLD) will be offered to participate in study. This is a 6-month prospective, randomized control trial enrolling patients referred to the Children's Medical Center CoaCH Program. The CoaCH Program is a medical weight management clinic, which serves obese children in order to diagnose and treat associated co-morbid conditions. To that end, we work with families to lessen energy intake and improve energy expenditure. Patients who are referred to CoaCH clinic undergo a standardized work up including assessment for associated co-morbidities. Patients who are identified to have fatty liver disease based on laboratory or radiologic imaging are then sent to a Pediatric Gastroenterologist as standard of care. additional work up including serologic testing, imaging and a liver biopsy is performed to identify the etiology of the liver disease present. as a step up in therapy, committed patients and families are enrolled in our PioneeR (Pediatric intensive obesity nutrition education and exercise Rehabilitation) clinic which is a 6 month intensive obesity management program. Patients enrolled in PioneeR who has completed a standard of care work up confirming naFLD will be pre-screened to identify those that meet the inclusion criteria and none of the exclusion criteria. Patients identified will be offered participation in the study and will either be given a consent form to take home during their pre-screening visit, contacted by phone or scheduled to come into clinic if more detail is requested. For those offered participation, consent and assent will be obtained by study personnel. if all criteria are met, the patient will be randomized to either a calorie restricted balanced diet (healthy lifestyle diet) or a carbohydrate restricted diet. Subjects will then be committed to this fixed meal for 6 months and dietary education will be given. This will include the allowed caloric intake and content, which is calculated by a bioelectrical impedance meter (Ge in body 520) specific to patient's age, gender and weight. This is calculated by the equation below: Total daily calories (kcal/day) [?] BMR (Basal metabolic rate) + 200kcal While undergoing the assigned dietary intervention both arms will be advised to take a multivitamin supplement that will be purchased by the patient and is not provided by the study. Patients will be seen by a psychologist that will help with goal setting. Dietary compliance will be followed closely and a 72-hour dietary recall will be conducted by our dietician on visit 1, 3 and 7. a baseline eKG to evaluate for heart disease and 1H-MRS to assess liver steatosis will be performed. Patients must have a working telephone number to enroll in the study. Weekly phone contact will be made for the first 12 weeks by our research personnel. Patients will be followed monthly through our PioneeR clinic (refer to appendix 1). Throughout the study blood and urine tests will be obtained to ensure safety while undergoing the prescribed diet. a 1H-MRS will be obtained after 2 months on the assigned dietary intervention to evaluate the short term response. once they have completed the 6-month dietary intervention, they will be seen in clinic and repeat blood, urine and a 1H-MRS will be performed. a liver biopsy will be attained after the 6 month dietary intervention to assess histologic improvement and response to treatment.
1. Age 11 x 17 years 2. Male and Female subjects 3. BMI >= 95th percentile according to CDC body mass index chart for age and gender 4. Must be willing to participate and undergo * willingness to change * evaluation 5. Metabolic Syndrome(MetS) which is defined when 3 of the following are met: a. Central adiposity (waist circumference >=90th% for age and sex) b. Hypertriglyceridemia (triglycerides >= 110mg/dl) c. Low HDL cholesterol <=40mg/dl d. Elevated blood pressure systolic or diastolic blood pressure > 90th % adjusted for age, sex and height or >= 130/85 e. IFG (Impaired fasting glucose >= 100mg/dl or elevated HOMA- IR >=3.16) 6. ALT greater than 60 U/L and Non Alcoholic Fatty Liver Disease based on histologic confirmation on liver biopsy (minimum of 5% of hepatocytes with macrovesicular fat) obtained within 6 months before randomization
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Charina Marie Ramirez