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Trial record 1 of 1 for:    ALANINE AMINOTRANSFERASE, PLASMA LEVEL OF, QUANTITATIVE TRAIT LOCUS 1
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Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01556113
First received: March 12, 2012
Last updated: April 26, 2017
Last verified: April 2017
  Purpose

To explore whether there is a different response to omega-3 fatty acid rich diet with respect to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor allele (GG) and the common allele homozygous (CC) of PNPLA3.

Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention than the common allele homozygous supplementation.


Condition Intervention
Non Alcoholic Fatty Liver Disease Steatohepatitis Hypertriglyceridemia Alanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1 Other: Omega diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The Genetic Effect on Omega 3 Fatty Acid Supplementation for the Treatment of Non Alcoholic Fatty Liver Disease in Obese Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • reduction in hepatic fat fraction [ Time Frame: 12 weeks ]
    subjects follow study designed meal plan


Secondary Outcome Measures:
  • reduction in triglycerides [ Time Frame: 12 weeks ]
    subjects follow study designed meal plan

  • lower ALT levels [ Time Frame: 12 weeks ]
    subjects follow study designed meal plan


Enrollment: 17
Actual Study Start Date: March 2012
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: omega diet carrying CC/CG genotype
Subjects homozygous for the major allele of the rs73049 SNP or heterozygous (CC and CG)
Other: Omega diet
Eligible subjects will receive omega rich diet for 12 weeks with weekly appointments to obtain food records, draw serum samples and provide meals.
Active Comparator: omega diet carrying GG genotype
Subjects homozygous for the minor allele of the rs73049 SNP (GG)
Other: Omega diet
Eligible subjects will receive omega rich diet for 12 weeks with weekly appointments to obtain food records, draw serum samples and provide meals.

Detailed Description:

Nonalcoholic fatty liver disease (NAFLD) is emerging as one of the most common complications of childhood obesity. It is associated with and predicts the metabolic syndrome, independent of overall obesity. Increased ALT levels are associated with deterioration in insulin sensitivity and glucose tolerance, as well as with increasing free fatty acid (FFA) and triglyceride levels. The prevalence of metabolic syndrome and prediabetes increases with the increases in hepatic fat content in a cohort of obese adolescents.

Fatty liver, independent of visceral and intramyocellular lipid content plays a central role in the impairment of liver, muscle and adipose insulin sensitivity in obese adolescents. Thus, fatty liver disease may be the hepatic component of the metabolic syndrome.

Omega 3 fatty acids lower plasma triglyceride concentrations. The subjects entering the omega diet study will be consuming an omega rich diet that is tailored to their caloric needs. This calculation is based on the patient's weight, age, and gender with the purpose of not modifying their weight at all. Weight maintenance is a very important factor in this arm of the study. They will be on the diet for 12 weeks.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10 to 19 years of age
  • BMI equal or greater than the 95th percentile for age and gender
  • Genotype PNPLA3 CC or GG
  • Liver MRI Hepatic Fat fraction ≥5.5%

Exclusion Criteria:

  • Food allergy to fish or any components of the pills which include alpha tocopherol partially hydrogenated vegetable oils including soybean oils, gelatin, glycerol, corn or iron oxide
  • Pregnant or breastfeeding
  • Known bleeding disorder or coagulopathy or treatment with anticoagulant mechanisms or low platelet counts, abnormal PT or PTT
  • Impaired glucose tolerance, Type 1 or 2 diabetes
  • Birth control pills
  • Alcohol consumption
  • Other liver disease
  • Taking any medication that alters triglyceride levels, liver function, blood pressure, glucose or lipid metabolism
  • Taking over the counter supplements that affect triglycerides or lipid metabolism including fish oil supplements
  • Treatment for or diagnosis of thyroid disorder or have an elevated TSH at baseline
  • Use of any antipsychotic medication
  • Taking chronic anti-inflammatory medications
  • Less than 100 pounds (45 kg)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556113

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Nicola Santoro, MD/PhD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01556113     History of Changes
Other Study ID Numbers: 1112009408
R01HD040787 ( US NIH Grant/Contract Award Number )
Study First Received: March 12, 2012
Last Updated: April 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Yale University:
fatty liver
hypertriglyceridemia
elevated liver enzymes

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Hypertriglyceridemia
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 23, 2017