Trial Outcomes & Findings for The Role of Obstructive Sleep Apnea in Children With Fatty Liver Disease (NCT NCT02134522)

NCT ID: NCT02134522

Last Updated: 2018-06-08

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2018-06-08

Participant Flow

Participant milestones

Measure	C-pap Intervention Subjects who underwent measurement of the hepatic fat content before and after the C-pap
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	C-pap Intervention n=1 Participants Subjects undergoing measurements of hepatic fat content before and after C-pap
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Gender · Female	0 Participants n=5 Participants
Sex: Female, Male Gender · Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Presented is the change from baseline to 12 weeks in a single patient.

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

Outcome measures

Measure	C-pap Intervention n=1 Participants Subjects who underwent the measure of hepatic fat content before and after the C-pap
Changes in Hepatic Fat Content	-4.8 percentage of hepatic liver fat

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	C-pap Intervention n=1 Participants Subjects who underwent the measure of hepatic fat content before and after the C-pap
Changes in Two Hour Glucose	5 mg/dl

Adverse Events

C-PAP Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicola Santoro

Yale University

Phone: 2037376356

Email: nicola.santoro@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place