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The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT02134522
Recruitment Status : Terminated (We were not able to recruit participants.)
First Posted : May 9, 2014
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE May 7, 2014
First Posted Date  ICMJE May 9, 2014
Results First Submitted Date  ICMJE February 21, 2018
Results First Posted Date  ICMJE June 8, 2018
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Changes in Hepatic Fat Content [ Time Frame: baseline and 12 weeks ]
Abdominal MRI to measure percent liver fat done at baseline and 12 weeks.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Hepatic Fat Fraction [ Time Frame: baseline ]
    Abdominal MRI to measure liver fat and subcutaneous and visceral fat ratio done at baseline, 4 weeks, 8 weeks, and 12 weeks.
  • Hepatic Fat Fraction [ Time Frame: 4 weeks ]
    Abdominal MRI to measure liver fat and subcutaneous and visceral fat ratio done at baseline, 4 weeks, 8 weeks, and 12 weeks.
  • Hepatic Fat Fraction [ Time Frame: 8 weeks ]
    Abdominal MRI to measure liver fat and subcutaneous and visceral fat ratio done at baseline, 4 weeks, 8 weeks, and 12 weeks.
  • Hepatic Fat Fraction [ Time Frame: 12 weeks ]
    Abdominal MRI to measure liver fat and subcutaneous and visceral fat ratio done at baseline, 4 weeks, 8 weeks, and 12 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Changes in Two Hour Glucose [ Time Frame: baseline and 12 weeks ]
2 hour glucose measured by an oral glucose tolerance test done at baseline and 12 weeks. Data are presented as mg/dl.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Glucose Tolerance [ Time Frame: 12 weeks ]
    Glucose tolerance status measured by 3 hour oral glucose tolerance test done at baseline and 12 weeks.
  • Glucose Tolerance [ Time Frame: Baseline ]
    Glucose tolerance status measured by 3 hour oral glucose tolerance test done at baseline and 12 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease
Official Title  ICMJE The Role of Obstructive Sleep Apnea in the Pathogenesis of Hepatic Steatosis in Obese Children and Adolescents
Brief Summary The purpose of this study is to examine whether CPAP therapy can reduce or eliminate hepatic fat accumulation in obese children and adolescents.
Detailed Description 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. Recently, studies in obese adolescents have demonstrated that increased ALT levels are associated with deterioration in insulin sensitivity and glucose tolerance, as well as with increasing FFA and triglyceride levels. Further studies showed that the prevalence of metabolic syndrome and prediabetes increases with the increases in hepatic fat content in a cohort of obese adolescents. Moreover, the investigators found that the fatty liver is associated with a pronounced dyslipidemic profile characterized by large VLDL, small dense LDL, and decreased large HDL concentrations. 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. The synthesis of triglycerides in the liver is nutritionally regulated, and its formation from simple carbohydrates requires multiple metabolic pathways, including glycolysis and pyruvate oxidation to generate acetyl-CoA for fatty acid synthesis, NADPH generation to supply the reductive power, packaging of fatty acids into a glycerophosphate backbone, and finally, lipoprotein packaging to export triglycerides. Recent studies have shown an association between fatty liver and obstructive sleep apnea (OSA), a condition that has been estimated to affect up to 27% of obese children. In particular, OSA has been associated with the ALT levels and with the degree of steatohepatitis. Despite those evidences and the importance of NAFLD in the development of metabolic diseases, the information concerning the association between fatty liver and OSA in obese children and adolescents is quite sparse and in particular is unclear whether OSA itself can cause NAFLD or the two conditions just coexist as obesity complications. In this study the investigators will test the hypothesis that OSA is one of the determinants of hepatic fat accumulation. To prove the investigators hypothesis the investigators will select a group of individuals with NAFLD and OSA, who will undergo a weight maintenance diet and Continuous Positive Airway Pressure (CPAP) for 12 weeks. CPAP is FDA approved and represents the leading therapy for obstructive sleep apnea in children over age 7 and 40 lbs. To evaluate the effect of the CPAP on the intra hepatic fat accumulation the investigators will evaluate hepatic fat content with MRI at baseline and after the intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Alcoholic Fatty Liver Disease
Intervention  ICMJE Device: Continuous positive airway pressure (CPAP).
Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults.
Other Name: c-pap
Study Arms  ICMJE Experimental: C-PAP intervention
Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults.
Intervention: Device: Continuous positive airway pressure (CPAP).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 25, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
15
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sleep Apnea as diagnosed by clinical sleep study (Apnea Hypopnea index greater than 1)
  • Evidence of NAFLD as diagnosed by screening MRI (hepatic fat fraction ≥5.5%) Obese child/adolescent between 9-21 years old
  • Compliance with using C-pap as instructed

Exclusion Criteria:

  • Medications or know disease known to alter glucose or insulin metabolism such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil.
  • Type 2 Diabetes Mellitus
  • Medications for chronic anti-inflammatory effects
  • Consumption of alcohol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134522
Other Study ID Numbers  ICMJE 1404013732
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE American Heart Association
Investigators  ICMJE
Principal Investigator: Nicola Santoro, MD Yale University
PRS Account Yale University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP