Trial Outcomes & Findings for Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver (NCT NCT00323414)

NCT ID: NCT00323414

Last Updated: 2018-02-23

Results Overview

The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) is a score based on the liver biopsy. It represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8, with high scores indicating more activity.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2018-02-23

Participant Flow

Participant milestones

Measure	PUFA Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks	Placebo Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
Overall Study STARTED	18	19
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	PUFA Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks	Placebo Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver

Baseline characteristics by cohort

Measure	PUFA n=18 Participants Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks	Placebo n=19 Participants Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks	Total n=37 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	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

The non-alcoholic fatty liver disease (NAFLD) activity score (NAS) is a score based on the liver biopsy. It represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8, with high scores indicating more activity.

Outcome measures

Measure	PUFA n=18 Participants Active treatment with PUFA	Placebo n=19 Participants Placebo arm of therapy
Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS)	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 48 weeks

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.

Outcome measures

Measure	PUFA n=18 Participants Active treatment with PUFA	Placebo n=19 Participants Placebo arm of therapy
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Values	16.1 HOMA-IR index Standard Deviation 10.3	13.1 HOMA-IR index Standard Deviation 7.3

SECONDARY outcome

Timeframe: 48 weeks

Aspartate amino transferase (IU/dL) at 48 weeks

Outcome measures

Measure	PUFA n=18 Participants Active treatment with PUFA	Placebo n=19 Participants Placebo arm of therapy
Aspartate Amino Transferase (AST) Levels	41.7 IU/dL Standard Deviation 17.4	47.9 IU/dL Standard Deviation 38.1

SECONDARY outcome

Timeframe: 48 weeks

Alanine amino transferase (IU/dL) ay 48 weeks

Outcome measures

Measure	PUFA n=18 Participants Active treatment with PUFA	Placebo n=19 Participants Placebo arm of therapy
Alanine Amino Transferase (ALT) Levels	56.9 IU/dL Standard Deviation 30.9	59.6 IU/dL Standard Deviation 43.8

SECONDARY outcome

Timeframe: 48 weeks

Fasting blood glucose

Outcome measures

Measure	PUFA n=18 Participants Active treatment with PUFA	Placebo n=19 Participants Placebo arm of therapy
Blood Glucose Levels	150.4 mg/dL Standard Deviation 43.7	123.5 mg/dL Standard Deviation 22.9

SECONDARY outcome

Timeframe: 48 weeks

Hemoglobin A1c

Outcome measures

Measure	PUFA n=18 Participants Active treatment with PUFA	Placebo n=19 Participants Placebo arm of therapy
HbA1C Levels	7.5 mg/dL Standard Deviation 2.2	6.9 mg/dL Standard Deviation 1.1

Adverse Events

PUFA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PUFA n=18 participants at risk Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks	Placebo n=19 participants at risk Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
Surgical and medical procedures Post liver biopsy pain	0.00% 0/18 • 48 weeks Patient reported adverse events and abnormal laboratory tests were collected	5.3% 1/19 • Number of events 1 • 48 weeks Patient reported adverse events and abnormal laboratory tests were collected
Surgical and medical procedures Post liver biopsy bleeding	0.00% 0/18 • 48 weeks Patient reported adverse events and abnormal laboratory tests were collected	5.3% 1/19 • Number of events 1 • 48 weeks Patient reported adverse events and abnormal laboratory tests were collected

Other adverse events

Measure	PUFA n=18 participants at risk Purified EPA:DHA (360 mg EPA and 240 mg DHA) 6 gelcaps 3 capsules by mouth 2x per day x 48 weeks	Placebo n=19 participants at risk Gelcaps containing corn oil as placebo 6 capsules 3 capsules by mouth 2 x per day for 48 weeks
Surgical and medical procedures No tissue	5.6% 1/18 • Number of events 1 • 48 weeks Patient reported adverse events and abnormal laboratory tests were collected	0.00% 0/19 • 48 weeks Patient reported adverse events and abnormal laboratory tests were collected

Additional Information

Srinivasan Dasarathy MD

Cleveland Clinic Foundation

Phone: 216-444-2766

Email: dasaras@ccf.org

Results disclosure agreements

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