Trial Outcomes & Findings for Insulin Resistance in Non-alcoholic Fatty Liver Disease (NCT NCT01289639)

NCT ID: NCT01289639

Last Updated: 2017-08-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-08-17

Participant Flow

Participant milestones

Measure	Arm 1 matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Overall Study STARTED	5	6	0
Overall Study COMPLETED	4	6	0
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Arm 1 matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Insulin Resistance in Non-alcoholic Fatty Liver Disease

Baseline characteristics by cohort

Measure	Arm 1 n=5 Participants matching placebo for fenofibrate 1 po qd matching placebo for pioglitazone 1 po qd	Arm 2 n=6 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd	Total n=11 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 7.3 • n=5 Participants	54.17 years STANDARD_DEVIATION 5.08 • n=7 Participants	—	51.91 years STANDARD_DEVIATION 6.41 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	—	4 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	—	7 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	—	11 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Arm 1 n=4 Participants matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=6 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan	.85 ratio Standard Error .08	.60 ratio Standard Error .17	—

SECONDARY outcome

Timeframe: 0-6 months

Outcome measures

Measure	Arm 1 n=4 Participants matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=6 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Change in Alanine Aminotransferase (ALT) Levels	-11.5 U/L Standard Error 12.9	-15.2 U/L Standard Error 4.5	—

SECONDARY outcome

Timeframe: 0-6 months

Outcome measures

Measure	Arm 1 n=4 Participants matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=6 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT	.09 ratio Standard Error .10	-0.16 ratio Standard Error 0.1	—

SECONDARY outcome

Timeframe: 0-6 months

Change in the rate of glucose disposal (Rd) during the low dose clamp. During a clamp procedure, insulin is infused at a dose based on body size and a glucose solution is infused and the rate adjusted every 5 minutes based on a blood glucose reading to maintain the blood glucose stable at 90 mg/dl (normal level). Using glucose isotopes and the rate of the glucose infusion, we are then able to calculate how much glucose the liver is producing and how much glucose is being taken up into tissues. This provides a measure of insulin sensitivity.

Outcome measures

Measure	Arm 1 n=4 Participants matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=5 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Change in Peripheral Insulin Sensitivity	0.21 mg/minute/kg lean mass Standard Error 0.51	-0.42 mg/minute/kg lean mass Standard Error 0.49	—

SECONDARY outcome

Timeframe: 0-6 months

Outcome measures

Measure	Arm 1 n=4 Participants matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=6 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Change in Intra-abdominal Fat Area by CT Scan	885 mm2 Standard Error 874	108 mm2 Standard Error 3416	—

SECONDARY outcome

Timeframe: 0-6 months

Hepatic insulin sensitivity was determined using stable glucose isotope measurements during the low dose hyperinsulinemic euglycemic clamp to determine the rate of endogenous glucose production in the fasting state and in response to a low dose glucose infusion. The ability of insulin to suppress glucose, which is mainly produced by the liver, thus provides a measure of hepatic insulin sensitivity and is expressed as a percentage of the basal state. Change in the ability of low dose insulin to suppress endogenous glucose production during a labeled hyperinsulinemic euglycemic clamp.

Outcome measures

Measure	Arm 1 n=4 Participants matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=5 Participants micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Change in Hepatic Insulin Sensitivity	23.3 % change from baseline Standard Error 7.8	4.9 % change from baseline Standard Error 9.3	—

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1 n=5 participants at risk matching placebo for fenofibrate 1 capsule po qd matching placebo for pioglitazone 1 capsule po qd	Arm 2 n=6 participants at risk micronized fenofibrate 200 mg 1 po qd matching placebo for pioglitazone 1 po qd	Arm 3 pioglitazone 30 mg po qd matching placebo for fenofibrate 1 po qd
Blood and lymphatic system disorders leg edema	0.00% 0/5 • Baseline and monthly.	33.3% 2/6 • Number of events 2 • Baseline and monthly.	— 0/0 • Baseline and monthly.
General disorders vasovagal reaction	40.0% 2/5 • Number of events 2 • Baseline and monthly.	0.00% 0/6 • Baseline and monthly.	— 0/0 • Baseline and monthly.
Musculoskeletal and connective tissue disorders gout attack	20.0% 1/5 • Number of events 1 • Baseline and monthly.	33.3% 2/6 • Number of events 3 • Baseline and monthly.	— 0/0 • Baseline and monthly.
Renal and urinary disorders increased serum creatinine	0.00% 0/5 • Baseline and monthly.	33.3% 2/6 • Number of events 2 • Baseline and monthly.	— 0/0 • Baseline and monthly.

Additional Information

Kristina Utzschneider

VA Puget Sound Health Care System

Phone: 206-277-3568

Email: kutzschn@u.washington.edu

Results disclosure agreements

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