Trial Outcomes & Findings for Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD) (NCT NCT00940537)

Results Overview

We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

6 months

Results posted on

2018-06-15

Participant Flow

Subjects were recruited through the Center for Human Nutrition (CHN) beginning in July, 2009. Many had previously been enrolled in other CHN studies. The final subject was tested in December, 2009.

All enrolled subjects completed the study.

Participant milestones

Participant milestones
Measure	NAFLD Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)	Non-NAFLD Non-diabetic, obese with no previous diagnosis of NAFLD
Overall Study STARTED	5	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAFLD n=5 Participants Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)	Non-NAFLD n=9 Participants Non-diabetic, obese with no previous diagnosis of NAFLD	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 13 • n=5 Participants	46 years STANDARD_DEVIATION 12 • n=7 Participants	45 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.

Outcome measures

Outcome measures
Measure	NAFLD n=5 Participants Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)	Non-NAFLD n=9 Participants Non-diabetic, obese with no previous diagnosis of NAFLD
The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS. Siemens sequence	13.0 coefficient of variation Standard Error 9.6	23.5 coefficient of variation Standard Error 1.1
The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS. Optimized sequence	4.4 coefficient of variation Standard Error 3.9	9.7 coefficient of variation Standard Error 0.1

SECONDARY outcome

Timeframe: after a 12 hour fast and 2 hours post-prandial

We compared the intrahepatic triglyceride content in subjects after a 12 hour fast and 2 hours after eating a high fat, high carbohydrate meal. The measure reported here is for the pre and post prandial results given as the ratio of triglyceride signal to water signal. After showing its reliability, we chose to use the results from the optimized breath-hold sequence.

Outcome measures

Outcome measures
Measure	NAFLD n=5 Participants Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)	Non-NAFLD n=9 Participants Non-diabetic, obese with no previous diagnosis of NAFLD
The Hepatic Triglyceride Content Pre- and Post-prandial. fasting	30 ratio Standard Error 12	8 ratio Standard Error 7
The Hepatic Triglyceride Content Pre- and Post-prandial. post-prandial	27 ratio Standard Error 9	8 ratio Standard Error 7

SECONDARY outcome

Timeframe: baseline cross-sectional measurements

Population: This analysis was per protocol.

T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences

Outcome measures

Outcome measures
Measure	NAFLD n=14 Participants Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)	Non-NAFLD Non-diabetic, obese with no previous diagnosis of NAFLD
T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water Low IHTG	0.9 ratio Standard Deviation 0.1	—
T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water Medium IHTG	1.1 ratio Standard Deviation 0.1	—
T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water High IHTG	1.1 ratio Standard Deviation 0.1	—

Adverse Events

NAFLD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-NAFLD

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

Gary Skolnick

Washington University School of Medicine

Phone: 314-362-5292

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place