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

NCT02134522 | Terminated Results

• 1 other identifier: 1404013732
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

non alcoholic fatty liver; childhood obesity; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Changes in Hepatic Fat Content

  Abdominal MRI to measure percent liver fat done at baseline and 12 weeks.

  baseline and 12 weeks

Secondary Outcomes (1)

• Changes in Two Hour Glucose

  baseline and 12 weeks

Study Arms (1)

C-PAP intervention

EXPERIMENTAL

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.

Device: Continuous positive airway pressure (CPAP).

Interventions

Continuous positive airway pressure (CPAP). DEVICE

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.

Also known as: c-pap

C-PAP intervention

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• American Heart Association: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Pediatric Obesity; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Nicola Santoro
• Organization: Yale University

nicola.santoro@yale.edu

2037376356

Study Officials

• Nicola Santoro, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 8, 2018
• Results First Posted: June 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)